Table 1.

Univariate and Multivariate Analysis of Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment Attributed to an Adverse Event (n = 317) Compared With Those Who Completed Treatment (n = 4826)

CharacteristicNoncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826])
Univariate
Multivariate
NCT (%)OR95% CIP ValueAdjusted OR95% CIP Value
Regimen
 3HP-DOT (n = 2844) Ref.6.4Ref.Ref.Ref.Ref.Ref.Ref.
 9H-SAT (n = 2299)5.91.1.87–1.38.431.731.01–2.95.23
Age (y; median, 38)
 <38 (n = 2534)4.50.56.44–.71<.0010.61.47–.79<.001
 ≥38 (n = 2609) Ref.7.8Ref.Ref.Ref.Ref.Ref.Ref.
Sex
 Female (n = 2282) Ref.7.7Ref.Ref.Ref.
 Male (n = 2861)5.00.63.50–.79<.001
Race
 White (n = 2854) Ref.6.9Ref.Ref.Ref.Ref.Ref.Ref.
 Black (n = 1315)4.10.58.43–.79.0010.33.23–.47<.001
 Asian (n = 765)6.00.87.62–1.21.400.52.35–.78.001
 Othera (n = 209)10.11.52.94–2.43.090.88.51–1.53.65
Ethnicity
 Non-Hispanic (n = 3013) Ref.7.5Ref.Ref.Ref.
 Hispanic (n = 2130)4.20.54.42–.70<.001
HIV status
 Negative (n = 2518) Ref.6.1Ref.Ref.Ref.
 Positive (n = 121)4.10.66.27–1.64.37
 Unknown (n = 2504)6.31.03.82–1.30.78
Country of origin
 Non-US (n = 3133) Ref.5.5Ref.Ref.Ref.
 United States (n = 2010)7.21.341.07–1.68.01
Body mass index
 Underweight (n = 85)4.70.67.24–1.86.44
 Normal (n = 1464) Ref.6.9Ref.Ref.Ref.
 Overweight (n = 1827)6.50.94.71–1.24.66
 Obese (n = 1767)5.30.75.56–1.0.05
Education
 ≤8th grade (n = 931)3.80.39.26–.59<.0010.55.35–.87.01
 8th grade through some college (n = 3207)6.00.64.49–.83.0010.90.67–1.21.49
 ≥College degree (n = 1005) Ref.9.1Ref.Ref.Ref.Ref.Ref.Ref.
Incarcerationb
 No (n = 4860) Ref.6.1Ref.Ref.Ref.
 Yes (n = 283)7.81.31.83–2.05.25
Unemployed
 No (n = 4534) Ref.6.1Ref.Ref.Ref.
 Yes (n = 609)6.41.05.74–1.48.79
Homelessc
 No (n = 4760) Ref.6.2Ref.Ref.Ref.
 Yes (n = 383)6.31.02.66–1.57.93
Alcohol consumptiond
 No (n = 2406) Ref.5.4Ref.Ref.Ref.
 Use (n = 2382)6.61.24.97–1.57.08
 Abuse (n = 355)9.01.751.17–2.60.01
Intravenous drug use ever
 No (n = 4942) Ref.6.0Ref.Ref.Ref.
 Yes (n = 201)10.01.731.07–2.78.02
Cirrhosis, by self-report
 No (n = 4949) Ref.6.0Ref.Ref.Ref.
 Yes (n = 194)10.81.911.20–3.05.01
Current smokere
 No (n = 3642) Ref.5.8Ref.Ref.Ref.
 Yes (n = 1501)7.11.26.99–1.60.07
Methadone treatment
 No (n = 5035) Ref.6.1Ref.Ref.Ref.
 Yes (n = 108)8.31.40.70–2.79.34
 Enrollment sitef.01.02
Concomitant medications
 No (n = 2566) Ref.3.6Ref.Ref.Ref.Ref.Ref.Ref.
 Yes (n = 2577)8.72.531.98–3.25<.0011.861.42–2.44<.001
LTBI for contact tuberculosis
 No (n = 1769) Ref.7.1Ref.Ref.Ref.
 Yes (n = 3374)5.70.79.63–1.0.05
LTBI for tuberculin skin test converter
 No (n = 3292) Ref.5.7Ref.Ref.Ref.
 Yes (n = 1851)6.91.22.97–1.54.09
LTBI for fibrosis
 No (n = 4985) Ref.6.1Ref.Ref.Ref.
 Yes (n = 158)7.01.14.61–2.13.67
LTBI for HIV infection
 No (n = 5026) Ref.6.2Ref.Ref.Ref.
 Yes (n = 117)4.30.68.27–1.66.39
Having missed an early visitg
 No (n = 4936) Ref.6.2Ref.Ref.Ref.
 Yes (n = 207)4.80.77.40–1.46.42
Interaction terms
 Ethnicity × regimen
  3HP-DOT: Non-Hispanic vs Hispanic3.01.93–4.69<.001
  9H-SAT: Non-Hispanic vs Hispanic1.44.92–2.26.11
 Cirrhosis, by self-report × regimen
  3HP-DOT: Cirrhosis: yes vs no0.80.35–1.83.60
  9H-SAT-: Cirrhosis: yes vs no2.931.52–5.65.001
 Alcohol × sex
  Male
   Users vs no alcohol1.641.05–2.57.03
   Abusers vs no alcohol2.151.19–3.89.01
  Female
   Users vs no alcohol0.84.59–1.19.32
   Abusers vs no alcohol0.70.26–1.92.49
CharacteristicNoncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826])
Univariate
Multivariate
NCT (%)OR95% CIP ValueAdjusted OR95% CIP Value
Regimen
 3HP-DOT (n = 2844) Ref.6.4Ref.Ref.Ref.Ref.Ref.Ref.
 9H-SAT (n = 2299)5.91.1.87–1.38.431.731.01–2.95.23
Age (y; median, 38)
 <38 (n = 2534)4.50.56.44–.71<.0010.61.47–.79<.001
 ≥38 (n = 2609) Ref.7.8Ref.Ref.Ref.Ref.Ref.Ref.
Sex
 Female (n = 2282) Ref.7.7Ref.Ref.Ref.
 Male (n = 2861)5.00.63.50–.79<.001
Race
 White (n = 2854) Ref.6.9Ref.Ref.Ref.Ref.Ref.Ref.
 Black (n = 1315)4.10.58.43–.79.0010.33.23–.47<.001
 Asian (n = 765)6.00.87.62–1.21.400.52.35–.78.001
 Othera (n = 209)10.11.52.94–2.43.090.88.51–1.53.65
Ethnicity
 Non-Hispanic (n = 3013) Ref.7.5Ref.Ref.Ref.
 Hispanic (n = 2130)4.20.54.42–.70<.001
HIV status
 Negative (n = 2518) Ref.6.1Ref.Ref.Ref.
 Positive (n = 121)4.10.66.27–1.64.37
 Unknown (n = 2504)6.31.03.82–1.30.78
Country of origin
 Non-US (n = 3133) Ref.5.5Ref.Ref.Ref.
 United States (n = 2010)7.21.341.07–1.68.01
Body mass index
 Underweight (n = 85)4.70.67.24–1.86.44
 Normal (n = 1464) Ref.6.9Ref.Ref.Ref.
 Overweight (n = 1827)6.50.94.71–1.24.66
 Obese (n = 1767)5.30.75.56–1.0.05
Education
 ≤8th grade (n = 931)3.80.39.26–.59<.0010.55.35–.87.01
 8th grade through some college (n = 3207)6.00.64.49–.83.0010.90.67–1.21.49
 ≥College degree (n = 1005) Ref.9.1Ref.Ref.Ref.Ref.Ref.Ref.
Incarcerationb
 No (n = 4860) Ref.6.1Ref.Ref.Ref.
 Yes (n = 283)7.81.31.83–2.05.25
Unemployed
 No (n = 4534) Ref.6.1Ref.Ref.Ref.
 Yes (n = 609)6.41.05.74–1.48.79
Homelessc
 No (n = 4760) Ref.6.2Ref.Ref.Ref.
 Yes (n = 383)6.31.02.66–1.57.93
Alcohol consumptiond
 No (n = 2406) Ref.5.4Ref.Ref.Ref.
 Use (n = 2382)6.61.24.97–1.57.08
 Abuse (n = 355)9.01.751.17–2.60.01
Intravenous drug use ever
 No (n = 4942) Ref.6.0Ref.Ref.Ref.
 Yes (n = 201)10.01.731.07–2.78.02
Cirrhosis, by self-report
 No (n = 4949) Ref.6.0Ref.Ref.Ref.
 Yes (n = 194)10.81.911.20–3.05.01
Current smokere
 No (n = 3642) Ref.5.8Ref.Ref.Ref.
 Yes (n = 1501)7.11.26.99–1.60.07
Methadone treatment
 No (n = 5035) Ref.6.1Ref.Ref.Ref.
 Yes (n = 108)8.31.40.70–2.79.34
 Enrollment sitef.01.02
Concomitant medications
 No (n = 2566) Ref.3.6Ref.Ref.Ref.Ref.Ref.Ref.
 Yes (n = 2577)8.72.531.98–3.25<.0011.861.42–2.44<.001
LTBI for contact tuberculosis
 No (n = 1769) Ref.7.1Ref.Ref.Ref.
 Yes (n = 3374)5.70.79.63–1.0.05
LTBI for tuberculin skin test converter
 No (n = 3292) Ref.5.7Ref.Ref.Ref.
 Yes (n = 1851)6.91.22.97–1.54.09
LTBI for fibrosis
 No (n = 4985) Ref.6.1Ref.Ref.Ref.
 Yes (n = 158)7.01.14.61–2.13.67
LTBI for HIV infection
 No (n = 5026) Ref.6.2Ref.Ref.Ref.
 Yes (n = 117)4.30.68.27–1.66.39
Having missed an early visitg
 No (n = 4936) Ref.6.2Ref.Ref.Ref.
 Yes (n = 207)4.80.77.40–1.46.42
Interaction terms
 Ethnicity × regimen
  3HP-DOT: Non-Hispanic vs Hispanic3.01.93–4.69<.001
  9H-SAT: Non-Hispanic vs Hispanic1.44.92–2.26.11
 Cirrhosis, by self-report × regimen
  3HP-DOT: Cirrhosis: yes vs no0.80.35–1.83.60
  9H-SAT-: Cirrhosis: yes vs no2.931.52–5.65.001
 Alcohol × sex
  Male
   Users vs no alcohol1.641.05–2.57.03
   Abusers vs no alcohol2.151.19–3.89.01
  Female
   Users vs no alcohol0.84.59–1.19.32
   Abusers vs no alcohol0.70.26–1.92.49

Regimen factor is also part of certain interaction terms. Blank cells indicate not applicable or not tested. Use of a less stringent entry criterion (P ≤ .2) produced the same final model.

Abbreviations: 3HP-DOT, 3 months of directly observed once-weekly rifapentine (maximum dose, 900 mg) plus isoniazid (maximum dose, 900 mg); 9H-SAT, 9 months of daily self-administered isoniazid (maximum dose, 300 mg); CI, confidence interval; HIV, human immunodeficiency virus; LTBI, latent tuberculosis infection; NCT, noncompletion of treatment; OR, odds ratio; Ref., reference.

a Includes North American Indian and other participants in the United States and Canada.

b History of living in a correctional institution for ≥1 month before enrollment.

c History of homelessness or living in a shelter or single-room occupancy for ≥6 months before enrollment.

d Use: affirmative response to a question asking whether the participant ever drank alcoholic beverages. Abuse: score of ≥2 on the Cut down, Annoyed, Guilty, and Eye-opener questionnaire [9].

e Smoking was ascertained on the basis of the patient's statement of whether smoking was current at time of enrollment.

f Enrollment site was analyzed as the random effect variable of a generalized linear mixed model. Two-tailed P value was calculated on the basis of the z score (estimate/standard error).

g Missing ≥1 of the first 3 directly observed therapy (DOT) sessions for the 3HP regimen or ≥1 of the 3 monthly clinic visits for the 9H regimen, followed by a DOT or a monthly visit, respectively. The variable includes those who did not receive any study dose (n = 148). In the univariate analysis, the need for an interpreter among non-US- or non-Canadian-born participants (n = 3133 [use = 1355; no use = 1778]) resulted in statistical significance (OR, 0.55; 95% CI, .40–.77; P = .001) among participants who did not complete treatment attributed to an adverse event.

Table 1.

Univariate and Multivariate Analysis of Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment Attributed to an Adverse Event (n = 317) Compared With Those Who Completed Treatment (n = 4826)

CharacteristicNoncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826])
Univariate
Multivariate
NCT (%)OR95% CIP ValueAdjusted OR95% CIP Value
Regimen
 3HP-DOT (n = 2844) Ref.6.4Ref.Ref.Ref.Ref.Ref.Ref.
 9H-SAT (n = 2299)5.91.1.87–1.38.431.731.01–2.95.23
Age (y; median, 38)
 <38 (n = 2534)4.50.56.44–.71<.0010.61.47–.79<.001
 ≥38 (n = 2609) Ref.7.8Ref.Ref.Ref.Ref.Ref.Ref.
Sex
 Female (n = 2282) Ref.7.7Ref.Ref.Ref.
 Male (n = 2861)5.00.63.50–.79<.001
Race
 White (n = 2854) Ref.6.9Ref.Ref.Ref.Ref.Ref.Ref.
 Black (n = 1315)4.10.58.43–.79.0010.33.23–.47<.001
 Asian (n = 765)6.00.87.62–1.21.400.52.35–.78.001
 Othera (n = 209)10.11.52.94–2.43.090.88.51–1.53.65
Ethnicity
 Non-Hispanic (n = 3013) Ref.7.5Ref.Ref.Ref.
 Hispanic (n = 2130)4.20.54.42–.70<.001
HIV status
 Negative (n = 2518) Ref.6.1Ref.Ref.Ref.
 Positive (n = 121)4.10.66.27–1.64.37
 Unknown (n = 2504)6.31.03.82–1.30.78
Country of origin
 Non-US (n = 3133) Ref.5.5Ref.Ref.Ref.
 United States (n = 2010)7.21.341.07–1.68.01
Body mass index
 Underweight (n = 85)4.70.67.24–1.86.44
 Normal (n = 1464) Ref.6.9Ref.Ref.Ref.
 Overweight (n = 1827)6.50.94.71–1.24.66
 Obese (n = 1767)5.30.75.56–1.0.05
Education
 ≤8th grade (n = 931)3.80.39.26–.59<.0010.55.35–.87.01
 8th grade through some college (n = 3207)6.00.64.49–.83.0010.90.67–1.21.49
 ≥College degree (n = 1005) Ref.9.1Ref.Ref.Ref.Ref.Ref.Ref.
Incarcerationb
 No (n = 4860) Ref.6.1Ref.Ref.Ref.
 Yes (n = 283)7.81.31.83–2.05.25
Unemployed
 No (n = 4534) Ref.6.1Ref.Ref.Ref.
 Yes (n = 609)6.41.05.74–1.48.79
Homelessc
 No (n = 4760) Ref.6.2Ref.Ref.Ref.
 Yes (n = 383)6.31.02.66–1.57.93
Alcohol consumptiond
 No (n = 2406) Ref.5.4Ref.Ref.Ref.
 Use (n = 2382)6.61.24.97–1.57.08
 Abuse (n = 355)9.01.751.17–2.60.01
Intravenous drug use ever
 No (n = 4942) Ref.6.0Ref.Ref.Ref.
 Yes (n = 201)10.01.731.07–2.78.02
Cirrhosis, by self-report
 No (n = 4949) Ref.6.0Ref.Ref.Ref.
 Yes (n = 194)10.81.911.20–3.05.01
Current smokere
 No (n = 3642) Ref.5.8Ref.Ref.Ref.
 Yes (n = 1501)7.11.26.99–1.60.07
Methadone treatment
 No (n = 5035) Ref.6.1Ref.Ref.Ref.
 Yes (n = 108)8.31.40.70–2.79.34
 Enrollment sitef.01.02
Concomitant medications
 No (n = 2566) Ref.3.6Ref.Ref.Ref.Ref.Ref.Ref.
 Yes (n = 2577)8.72.531.98–3.25<.0011.861.42–2.44<.001
LTBI for contact tuberculosis
 No (n = 1769) Ref.7.1Ref.Ref.Ref.
 Yes (n = 3374)5.70.79.63–1.0.05
LTBI for tuberculin skin test converter
 No (n = 3292) Ref.5.7Ref.Ref.Ref.
 Yes (n = 1851)6.91.22.97–1.54.09
LTBI for fibrosis
 No (n = 4985) Ref.6.1Ref.Ref.Ref.
 Yes (n = 158)7.01.14.61–2.13.67
LTBI for HIV infection
 No (n = 5026) Ref.6.2Ref.Ref.Ref.
 Yes (n = 117)4.30.68.27–1.66.39
Having missed an early visitg
 No (n = 4936) Ref.6.2Ref.Ref.Ref.
 Yes (n = 207)4.80.77.40–1.46.42
Interaction terms
 Ethnicity × regimen
  3HP-DOT: Non-Hispanic vs Hispanic3.01.93–4.69<.001
  9H-SAT: Non-Hispanic vs Hispanic1.44.92–2.26.11
 Cirrhosis, by self-report × regimen
  3HP-DOT: Cirrhosis: yes vs no0.80.35–1.83.60
  9H-SAT-: Cirrhosis: yes vs no2.931.52–5.65.001
 Alcohol × sex
  Male
   Users vs no alcohol1.641.05–2.57.03
   Abusers vs no alcohol2.151.19–3.89.01
  Female
   Users vs no alcohol0.84.59–1.19.32
   Abusers vs no alcohol0.70.26–1.92.49
CharacteristicNoncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826])
Univariate
Multivariate
NCT (%)OR95% CIP ValueAdjusted OR95% CIP Value
Regimen
 3HP-DOT (n = 2844) Ref.6.4Ref.Ref.Ref.Ref.Ref.Ref.
 9H-SAT (n = 2299)5.91.1.87–1.38.431.731.01–2.95.23
Age (y; median, 38)
 <38 (n = 2534)4.50.56.44–.71<.0010.61.47–.79<.001
 ≥38 (n = 2609) Ref.7.8Ref.Ref.Ref.Ref.Ref.Ref.
Sex
 Female (n = 2282) Ref.7.7Ref.Ref.Ref.
 Male (n = 2861)5.00.63.50–.79<.001
Race
 White (n = 2854) Ref.6.9Ref.Ref.Ref.Ref.Ref.Ref.
 Black (n = 1315)4.10.58.43–.79.0010.33.23–.47<.001
 Asian (n = 765)6.00.87.62–1.21.400.52.35–.78.001
 Othera (n = 209)10.11.52.94–2.43.090.88.51–1.53.65
Ethnicity
 Non-Hispanic (n = 3013) Ref.7.5Ref.Ref.Ref.
 Hispanic (n = 2130)4.20.54.42–.70<.001
HIV status
 Negative (n = 2518) Ref.6.1Ref.Ref.Ref.
 Positive (n = 121)4.10.66.27–1.64.37
 Unknown (n = 2504)6.31.03.82–1.30.78
Country of origin
 Non-US (n = 3133) Ref.5.5Ref.Ref.Ref.
 United States (n = 2010)7.21.341.07–1.68.01
Body mass index
 Underweight (n = 85)4.70.67.24–1.86.44
 Normal (n = 1464) Ref.6.9Ref.Ref.Ref.
 Overweight (n = 1827)6.50.94.71–1.24.66
 Obese (n = 1767)5.30.75.56–1.0.05
Education
 ≤8th grade (n = 931)3.80.39.26–.59<.0010.55.35–.87.01
 8th grade through some college (n = 3207)6.00.64.49–.83.0010.90.67–1.21.49
 ≥College degree (n = 1005) Ref.9.1Ref.Ref.Ref.Ref.Ref.Ref.
Incarcerationb
 No (n = 4860) Ref.6.1Ref.Ref.Ref.
 Yes (n = 283)7.81.31.83–2.05.25
Unemployed
 No (n = 4534) Ref.6.1Ref.Ref.Ref.
 Yes (n = 609)6.41.05.74–1.48.79
Homelessc
 No (n = 4760) Ref.6.2Ref.Ref.Ref.
 Yes (n = 383)6.31.02.66–1.57.93
Alcohol consumptiond
 No (n = 2406) Ref.5.4Ref.Ref.Ref.
 Use (n = 2382)6.61.24.97–1.57.08
 Abuse (n = 355)9.01.751.17–2.60.01
Intravenous drug use ever
 No (n = 4942) Ref.6.0Ref.Ref.Ref.
 Yes (n = 201)10.01.731.07–2.78.02
Cirrhosis, by self-report
 No (n = 4949) Ref.6.0Ref.Ref.Ref.
 Yes (n = 194)10.81.911.20–3.05.01
Current smokere
 No (n = 3642) Ref.5.8Ref.Ref.Ref.
 Yes (n = 1501)7.11.26.99–1.60.07
Methadone treatment
 No (n = 5035) Ref.6.1Ref.Ref.Ref.
 Yes (n = 108)8.31.40.70–2.79.34
 Enrollment sitef.01.02
Concomitant medications
 No (n = 2566) Ref.3.6Ref.Ref.Ref.Ref.Ref.Ref.
 Yes (n = 2577)8.72.531.98–3.25<.0011.861.42–2.44<.001
LTBI for contact tuberculosis
 No (n = 1769) Ref.7.1Ref.Ref.Ref.
 Yes (n = 3374)5.70.79.63–1.0.05
LTBI for tuberculin skin test converter
 No (n = 3292) Ref.5.7Ref.Ref.Ref.
 Yes (n = 1851)6.91.22.97–1.54.09
LTBI for fibrosis
 No (n = 4985) Ref.6.1Ref.Ref.Ref.
 Yes (n = 158)7.01.14.61–2.13.67
LTBI for HIV infection
 No (n = 5026) Ref.6.2Ref.Ref.Ref.
 Yes (n = 117)4.30.68.27–1.66.39
Having missed an early visitg
 No (n = 4936) Ref.6.2Ref.Ref.Ref.
 Yes (n = 207)4.80.77.40–1.46.42
Interaction terms
 Ethnicity × regimen
  3HP-DOT: Non-Hispanic vs Hispanic3.01.93–4.69<.001
  9H-SAT: Non-Hispanic vs Hispanic1.44.92–2.26.11
 Cirrhosis, by self-report × regimen
  3HP-DOT: Cirrhosis: yes vs no0.80.35–1.83.60
  9H-SAT-: Cirrhosis: yes vs no2.931.52–5.65.001
 Alcohol × sex
  Male
   Users vs no alcohol1.641.05–2.57.03
   Abusers vs no alcohol2.151.19–3.89.01
  Female
   Users vs no alcohol0.84.59–1.19.32
   Abusers vs no alcohol0.70.26–1.92.49

Regimen factor is also part of certain interaction terms. Blank cells indicate not applicable or not tested. Use of a less stringent entry criterion (P ≤ .2) produced the same final model.

Abbreviations: 3HP-DOT, 3 months of directly observed once-weekly rifapentine (maximum dose, 900 mg) plus isoniazid (maximum dose, 900 mg); 9H-SAT, 9 months of daily self-administered isoniazid (maximum dose, 300 mg); CI, confidence interval; HIV, human immunodeficiency virus; LTBI, latent tuberculosis infection; NCT, noncompletion of treatment; OR, odds ratio; Ref., reference.

a Includes North American Indian and other participants in the United States and Canada.

b History of living in a correctional institution for ≥1 month before enrollment.

c History of homelessness or living in a shelter or single-room occupancy for ≥6 months before enrollment.

d Use: affirmative response to a question asking whether the participant ever drank alcoholic beverages. Abuse: score of ≥2 on the Cut down, Annoyed, Guilty, and Eye-opener questionnaire [9].

e Smoking was ascertained on the basis of the patient's statement of whether smoking was current at time of enrollment.

f Enrollment site was analyzed as the random effect variable of a generalized linear mixed model. Two-tailed P value was calculated on the basis of the z score (estimate/standard error).

g Missing ≥1 of the first 3 directly observed therapy (DOT) sessions for the 3HP regimen or ≥1 of the 3 monthly clinic visits for the 9H regimen, followed by a DOT or a monthly visit, respectively. The variable includes those who did not receive any study dose (n = 148). In the univariate analysis, the need for an interpreter among non-US- or non-Canadian-born participants (n = 3133 [use = 1355; no use = 1778]) resulted in statistical significance (OR, 0.55; 95% CI, .40–.77; P = .001) among participants who did not complete treatment attributed to an adverse event.

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