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Through life dose uniformity testing of MDI units containing formulations of budesonide produced by the novel process, was consistent and within the limits specified by the FDA draft guidance on metered dose inhalers.
The median number of alcohol life dose units for the AUD group in the total cohort was 1125.50, where a unit refers to one beer or wine cooler, one glass of wine, or one 43 g shot of liquor (on its own, or in a mixed drink).> -wrap-foot>> -wraAlcohol aAlifeol life dose was measured in units.
As an additional 2 × 2 ANCOVA, we examined CTQ as a main effect and as an interaction with BDNF genotype, controlling for age, TMV and alcohol life dose as covariates.
The absence of associations in the Stokes et al. (1998) study could be because of the younger age of studied subjects, the very low current blood and tibia lead levels, or the inadequacy of tibia lead in the third decade of life to estimate early life dose (Hoppin et al. 2000).
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Because the optimal period between booster doses is not known, most countries with adult pertussis booster policies recommend a single life-time dose.
Laboratory parameters were examined at baseline, the end of the real- life dose-optimization phase, and the end of the study.
During the 5-week real- life dose-optimization phase, the MPH-LA AE profile was similar to that observed during the initial phase.
Of the 725 patients randomized at phase 1 baseline, 584 (80.6%) patients completed the 9-week doublindblindose-confirmationon phase and entered the real- life dose-optimization phase.
The real- life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double- blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase.
DSM-IV ADHD RS and CGI-I scores were assessed at weeks 1, 2, 3, 5, 7, and 9 during the double- blind dose-confirmation phase; at every week during the 5-week real- life dose-optimization phase; and every 4 weeks during the 6-month maintenance of effect phase.
Assuming a 20% dropout rate in this initial dose-confirmation phase, a total of 700 randomized patients were required.> Assuming a responder rate of 80% and a dropout rate of 15% during the real- life dose-optimization phase, approximately 380 patients were expected to be re-randomized to placebo and MPH-LA with an allocation ratio of 1 3.
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