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rates, changes in marginal bone level and complication rates were comparable when high or regular insertion torques were used for implant placement. The wide confidence interval indicated that results cannot be interpreted with clinically meaningful benefit for using either high or regular insertion torque.Despite growing awareness of the dangers of a dichotomous interpretation of trial results based on the 'statistical significance' of a treatment effect, the uptake of new approaches has been slow in diabetes medicine. We showcase a number of ways to interpret the evidence for a treatment effect applied to the cardiovascular outcome trials of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT-2is) the P value function (or confidence curves), which depicts the treatment effect across the whole spectrum of confidence levels; the counternull value, which is the hazard ratio (i.e. treatment effect size) supported by the same amount of evidence as the null value (i.e. no treatment effect); and the S value, which quantifies the strength of the evidence against the null hypothesis in terms of the number of coin tosses yielding the same side. We show how this approach identifies potential treatment effects, highlights similarities among trials straddling the thresalues should complement the standard reporting of the treatment effect to help interpret clinical trials and make decisions among competing glucose-lowering medications.Determining an ecological and environment damage baseline is the foundation of natural resource damage assessment. In complex damage assessment, the importance of a baseline is often underestimated or ignored. Existing baseline determination methods are insufficiently accurate and poorly available in practical application, which affect the damage assessment work. Based on the definition of baseline and the shortcomings of existing baseline-determination methods, this paper suggests the original site point (OSP) method as a determination principle. BGB-283 The baseline calculation area can be directly determined according to the site conditions in a sludge storage site with clear pollution distribution, and the OSP method has the advantage of determining the baseline rapidly. For a waste oil sludge storage site with unclear pollution distribution, the baseline calculation area should be determined according to preliminary and detailed sampling data. The calculation results of the two sites indicate that the baseline determined using the OSP method and the reference point (RP) method are similar, and the results of the environmental standard (ES) method are superior to those of the other two methods. The order of accuracy of baseline determination methods is the historical data (HD) method > the OSP method > the RP method > the model calculation (MC) method > the ES method. Through two application cases, this paper discusses the applicability of the OSP method and finally establishes the determination steps of the method. The OSP method has proven effective in determining the baseline, and the fast and accurate baseline determination method is more helpful for damage assessment. Integr Environ Assess Manag 2021;001-11. © 2021 SETAC.The purpose of this study was to assess the effects of dietary humate substances (HS) and CloSTAT (Bacillus subtilis PB6) on the thyroid activity and histology, iron profile, blood haematology and performance of growing Japanese quail. A total of 216 unsexed 7-day-old quail chicks were randomly assigned to six groups. The first group was fed a basal diet (BD) without any additives (control); the 2nd group received BD plus 0.05% CloSTAT, the 3rd and 4th groups were given BD plus 0.4% and 0.8% HS, respectively; and the 5th and 6th groups were administered BD plus CloSTAT + 0.4% HS and BD plus CloSTAT + 0.8% HS, respectively. The results showed that the growth performance was improved with the addition of CloSTAT alone or in combination with 0.4% HS compared with the control. Haematological parameters, iron level and transferrin saturation % were significantly (p less then 0.001) increased by feeding HS compared with the control group. Serum thyroxin and triiodothyronine levels were significantly (p = 0.001) increased by adding CloSTAT relative to the control. Supplementation of 0.8% HS caused deterioration in histomorphometry parameters of the thyroid gland, but these parameters were improved in response to CloSTAT compared with the control. In conclusion, dietary B. subtilis PB6 as CloSTAT or CloSTAT + 0.4% HS supplementation may be efficacious in enhancing the growth performance and boosting the thyroid activity of growing Japanese quail. Moreover, the addition of 0.4% or 0.8% HS to quail diets boosted their iron profile and haematological parameters.The strict intake regimen of cysteamine bitartrate formulations, associated with side effects, is a concern for the treatment compliance in cystinosis therapy. Therefore, there is a need for a cysteamine formulation with an improved pharmacokinetic profile. This study investigated the pharmacokinetics, safety and tolerability of a new sustained-release cysteamine dosage form, PO-001, in healthy volunteers. This was a randomized, investigator-blinded, three-way cross-over study to compare single doses (600 mg) of PO-001 with Cystagon® (immediate-release) and Procysbi® (delayed-release). Collected blood samples were analyzed for plasma cysteamine concentrations and pharmacokinetic parameters were estimated by noncompartmental analysis. In addition, plasma cysteamine concentrations were analyzed using a population pharmacokinetic approach using NONMEM® . Pharmacokinetics showed clear sustained-release characteristics of PO-001 over time with a lower Cmax and longer Tmax compared to Cystagon® and Procysbi® . All treatment-emergent adverse events were of mild severity, with the exception of two subjects who reported moderate severity gastrointestinal problems including vomiting and diarrhea, which were related to Cystagon® intake. Population PK simulations showed a favourable PK profile based on Cmax and Ctrough concentrations at steady state. In conclusion, a single dose of 600 mg PO-001 was well tolerated with no findings of clinical concern. This new cysteamine bitartrate formulation showed pharmacokinetics of a sustained-release formulation, which may be beneficial for the treatment of cystinosis patients. This study supports advancing this type of sustained-release formulation into a subsequent study to confirm reduced dosing frequency with efficient control of white blood cells (WBCs) cystine levels. Netherlands Trial Registry (NTR) (NL67638.056.18).