Abstinence was judged according to subjects’ diaries, interviews with subjects and their attendants, breath alcohol concentration, and laboratory liver function tests (γ-glutamyl transpeptidase [GGTP], aspartate aminotransferase [AST], and alanine aminotransferase [ALT]). A breath alcohol concentration ≥ 0.05 mg/L resulted in an entry of “consumed alcohol” for the previous day. If the investigator found abnormally high values exceeding the site-specific standard ranges in the liver function test (GGTP, AST, and ALT), the investigator checked the subject for hepatopathy and ascertained the use of other concomitant drugs. If the investigator suspected that the subject had been drinking, the investigator interviewed the subject or his/her cooperative attendant and made a judgment as to whether the subject had been drinking, taking into account interview results, other test results, and the subject’s general condition. It is known that drinking tends to cause a marked increase in GGTP, AST, and ALT. However, the extent of the increase differs from individual to individual, and no cutoff value was defined. If it was determined on the basis of the test results that alcohol had been used, the first day of alcohol use was identified from information in the subject’s diary and the results of an interview with the subject and his/her cooperative attendant. In ambiguous cases, subjects were assumed to have consumed alcohol. Days for which a missing value was detected and days on which it was unknown
Abstinence was judged according to subjects’ diaries, interviews with subjects and their attendants, breath alcohol concentration, and laboratory liver function tests (γ-glutamyl transpeptidase [GGTP], aspartate aminotransferase [AST], and alanine aminotransferase [ALT]). A breath alcohol concentration ≥ 0.05 mg/L resulted in an entry of “consumed alcohol” for the previous day. If the investigator found abnormally high values exceeding the site-specific standard ranges in the liver function test (GGTP, AST, and ALT), the investigator checked the subject for hepatopathy and ascertained the use of other concomitant drugs. If the investigator suspected that the subject had been drinking, the investigator interviewed the subject or his/her cooperative attendant and made a judgment as to whether the subject had been drinking, taking into account interview results, other test results, and the subject’s general condition. It is known that drinking tends to cause a marked increase in GGTP, AST, and ALT. However, the extent of the increase differs from individual to individual, and no cutoff value was defined. If it was determined on the basis of the test results that alcohol had been used, the first day of alcohol use was identified from information in the subject’s diary and the results of an interview with the subject and his/her cooperative attendant. In ambiguous cases, subjects were assumed to have consumed alcohol. Days for which a missing value was detected and days on which it was unknown
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