The absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52 is reported.

The absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. only patients with baseline measurement and at least one post-baseline measurement are included.

Time to the first occurrence of any component of the composite endpoint-acute IPF exacerbation, hospitalization for a respiratory cause, or death (whichever occurred first)-is reported as the number of participants who experienced one or more of these events during the trial.

Acute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:

Acute worsening or development of dyspnea, typically of less than 1 month's duration.

Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.

Deterioration not fully explained by cardiac failure or fluid overload.

If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation, hospitalization, death.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

The time to first acute IPF exacerbation or death during the trial is reported as the number of participants who experienced either event.

Acute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:

Acute worsening or development of dyspnea, typically of less than 1 month's duration.

Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.

Deterioration not fully explained by cardiac failure or fluid overload.

If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

Time to hospitalization for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event.

Hospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis.

If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: hospitalization for respiratory cause, followed by death.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.

If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy; Absolute decline in FVC % predicted of > 10% followed by death.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

The time to absolute decline of more than 15% from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.

Predicted DLCO value was corrected for hemoglobin (Hb).

If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of > 15%, followed by Death.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

Time to death over the duration of the trial is reported as the number of participants who died.

Time to death will be based either on the date of death on the AE report for patients with AEs leading to death or will be based on the information from the vital status assessment.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.

The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline use of antifibrotic therapy, and baseline dyspnea score at each visit, with an unstructured covariance structure to model repeated measures.

The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:

Symptoms (23 items) and

Impacts (21 items).

The Symptoms module yields three domain scores:

Dyspnea,

Cough, and

Fatigue,

as well as a Total Symptoms score.

Scoring is based on the mean of item ratings within each domain, multiplied by 100.

Scores range from 0 to 100, with higher scores indicating greater impairment.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.

The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline L-PF Cough score at each visit, with an unstructured covariance matrix for repeated measures.

The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:

Symptoms (23 items) and

Impacts (21 items).

The Symptoms module yields three domain scores:

Dyspnea,

Cough, and

Fatigue,

as well as a Total Symptoms score.

Scoring is based on the mean of item ratings within each domain, multiplied by 100.

Scores range from 0 to 100, with higher scores indicating greater impairment.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.

The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at Week 52 is reported.

The analysis used a mixed model for repeated measures (MMRM) with fixed categorical effects for treatment, baseline antifibrotic (AF) therapy, and the fixed continuous effect of baseline L-PF score. Covariance was unstructured. Baseline AF therapy was a covariate.

The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:

Symptoms (23 items) and

Impacts (21 items).

The Symptoms module yields three domain scores:

Dyspnea,

Cough, and

Fatigue,

as well as a Total Symptoms score.

Scoring is based on the mean of item ratings within each domain, multiplied by 100.

Scores range from 0 to 100, with higher scores indicating greater impairment.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.

The absolute change from baseline in Forced Vital Capacity percent predicted at Week 52 is reported.

Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.

Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.

The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted at Week 52 is reported.

The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.

Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.

Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.