The safety analysis set for the evaluation of long-term safety (SAF-LTS) included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated)

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.

The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.

The ADA analysis set for the long-term safety population included all participants who received any study drug (SAF-LTS) and had at least 1 non-missing ADA result following the first dose of study drug.

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category.

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category.

The PGA of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category.

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score

The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category. Participants with missing data are considered as a non-response.