title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Pharmacokinetic assessment | BLOOD | Blood samples were collected for PK assessment before the first dose and at 1, 2, 3, 6, and 8 h after oral milademetan on days 1 and 14 of cycle 1, before the dose on days 2 and 8 of cycle 1, and before the dose and at 3 h after milademetan on day 1 of cycle 2. Milademetan concentrations were determined using a validat... | PMC9813109 | |
Pharmacodynamic assessment | To investigate biomarkers that could be potentially linked to the milademetan mechanism of action, blood, bone marrow, and serum were collected. | PMC9813109 | ||
Efficacy assessment | extramedullary leukemia, AML, SD | DISEASE, REMISSION, AML | Bone marrow and peripheral blood results were used to assess the antitumor effect of milademetan. AML response criteria were defined as shown in Supplementary Table 1. A morphologic leukemia-free state (MLFS) was defined as bone marrow blasts < 5% in the absence of blasts with Auer rods and the absence of extramedullar... | PMC9813109 |
Definitions and statistical analysis | DLTs, overdose | REGRESSION | All patients who received at least one milademetan dose were included in the safety analysis set. The MTD analysis set included patients who received at least one milademetan dose, had no missing data for examination or observation during the DLT evaluation period, and had a completed DLT evaluation. Without DLTs, the ... | PMC9813109 |
Results | AML | AML | This study protocol primarily evaluated the QD 14/28 milademetan schedule in AML patients. The QD 14/28 treatment schedule was required in this study to participate in another phase I study in combination with quizartinib (NCT03552029) [ | PMC9813109 |
Safety | death, pneumonia, febrile neutropenia, TEAEs, SAEs, TEAE | PNEUMONIA, FEBRILE NEUTROPENIA, ADVERSE EVENTS, EVENT, DISEASE, ADVERSE EVENT, EVENTS | The median (minimum and maximum) total treatment duration of the 14 patients was 1.5 (1 and 8) cycles. The median (minimum and maximum) relative dose intensity was 100% (92.9% and 100%), 100% (7.1% and 100%), and 92.9% (70.7% and 100%) in the 90-, 120-, and 160 mg cohorts, respectively. A summary of TEAEs is provided i... | PMC9813109 |
Pharmacodynamics (biomarker) | PMC9813109 | |||
TP53 genomic mutation status | A mutation in the | PMC9813109 | ||
MIC-1 status | MIC-1 is a secreted p53 downstream gene product used as a pharmacodynamic biomarker for p53 activation [Mean macrophage inhibitory cytokine-1 (MIC-1) serum level | PMC9813109 | ||
Discussion | nausea, DLTs, AML, vomiting, decreased appetite, heterogenous R/R | AML, DYSFUNCTION | This is the first report to evaluate the safety and tolerability of milademetan monotherapy administered in multiple doses for R/R AML patients. Of the 14 enrolled patients, 14, 12, and 11 were included in the safety, efficacy, and MTD analysis sets, respectively. The most common TEAEs were decreased appetite (64.3%) a... | PMC9813109 |
Acknowledgements | The authors thank the patients of this study and their families. All authors meet the International Committee of Medical Journal Editors criteria for authorship for this article and take responsibility for the integrity of the work, the data, and its accuracy. All authors had full access to the data in this study and t... | PMC9813109 | ||
Data availability | Deidentified individual patient data and applicable supporting clinical trial documents may be available upon request at Vivli-Center for Global Clinical Research Data. Daiichi Sankyo will continue to protect the privacy of the clinical trial patients in cases where clinical trial data and supporting documents are prov... | PMC9813109 | ||
Declarations | PMC9813109 | |||
Conflicts of interest | Naohiro Sekiguchi received research funds from Ono, A2 Healthcare, Astellas, Janssen, MSD, Otsuka, Pfizer, PPD-SNBL, Sumimoto Dainippon, Daiichi Sankyo, and Bristol Myers Squibb. Senji Kasahara received research funds from Daiichi Sankyo. Toshihiro Miyamoto received research funds from Daiichi Sankyo and speaker fees f... | PMC9813109 | ||
Ethical statement | This study was conducted and complied with all international and local laws, the principles of the Declaration of Helsinki, and the Good Clinical Practice Guidelines. All patients provided written voluntary informed consent to participate in this study. The study protocol and all its amendments were approved by the rel... | PMC9813109 | ||
References | PMC9813109 | |||
1. Introduction | TB, sepsis, Sepsis, human immunodeficiency virus (HIV) | SEPSIS, SEPSIS, DISEASES, TUBERCULOSIS (TB) | Sepsis is a significant cause of mortality among people living with human immunodeficiency virus (HIV) in sub-Saharan Africa. In the planning period prior to the start of a large multi-country clinical trial studying the efficacy of the immediate empiric addition of anti-tuberculosis therapy to standard-of-care antibio... | PMC10049353 |
2. Methods | PMC10049353 | |||
Study Model and Parameters | TB, infection, sepsis | INFECTION, SEPSIS | We constructed three distinct decision-analysis models to assess the cost-effectiveness of immediate empiric anti-TB treatment versus diagnosis-dependent standard of care using the three different TB diagnostic approaches (urine TB-LAM, sputum Xpert MTB/RIF, and LAM/Xpert) (Underlying TB prevalence rates in persons wit... | PMC10049353 |
3. Results | TB, sepsis | SEPSIS | Immediate empiric-therapy demonstrated favorable cost-effectiveness compared with all three diagnosis-dependent standard of care models (urine TB-LAM, sputum Xpert MTB/RIF, and the combination LAM/Xpert). Of the three cost effectiveness models, the sputum Xpert diagnostic strategy presented the most favorable increment... | PMC10049353 |
4. Discussion | TB | Here, we demonstrated an analytic approach that can provide early proof of concept of the potential costs and health utilities of a proposed randomized control trial demonstrating a mortality benefit to the hypothetical early empiric anti-TB therapy arm regardless of the diagnostic strategy used (urine LAM, sputum Xper... | PMC10049353 | |
Limitations | DISEASE, LENS | We caution that these results and the limited model horizon should not be extrapolated beyond the lens of the clinical trial period, as they only provide early estimates using the preliminary data to support the underlying clinical trial hypothesis, and the demonstrated need of the clinical trial to provide true effica... | PMC10049353 | |
Author Contributions | J.K.-M., S.K.H., T.A.T. and C.C.M. conceptualized the study. J.K.-M. and J.M.L. conducted the data analysis. S.K.H., T.A.T., C.C.M., S.G.M. and C.M. provided clinical domain knowledge and finalized model parameter estimates. J.K.-M. drafted the first draft of the manuscript. All authors have read and agreed to the publ... | PMC10049353 | ||
Institutional Review Board Statement | Not applicable, not research on human subjects. | PMC10049353 | ||
Informed Consent Statement | Not applicable. | PMC10049353 | ||
Data Availability Statement | Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. Additional model findings are available upon request. | PMC10049353 | ||
Conflicts of Interest | The authors declare that they have no competing interest. | PMC10049353 | ||
References | HIV and sepsis | Decision model of combined urine LAM+Xpert. In this model, we compare the two future arms of a randomized control trial. ‘Treat all’ means deliver early antimicrobial therapy in the context of suspected TB-sepsis and ‘selective treatment’ indicates standard of care (wait and treat once a diagnosis is confirmed. This ex... | PMC10049353 | |
Subject terms | NBIs | Adolescence is a time of multiple transitions and a vulnerability period for mental health difficulties. There are many barriers to the treatment of mental health conditions which is one reason for developing alternatives to help improve efficacy in treatment and prevention. One approach is to use nature-based interven... | PMC10584913 | |
Introduction | disability | Mental health difficulties are associated with high levels of disability globallyTraditionally, mental healthcare has been driven by our collective ‘rule of rescue’, focusing primarily on treatmentFor these reasons more focus on prevention interventions has been called for in many quartersNature-based interventions (NB... | PMC10584913 | |
Results | PMC10584913 | |||
Randomisation | We first checked whether there were differences between randomisation conditions on demographic information and the baseline measures. No differences were observed suggesting that the randomisation procedure was successful (see Table Means, standard deviations and proportions of baseline characteristics and study measu... | PMC10584913 | ||
The effect of nature exposure | PMC10584913 | |||
Stress & relaxation | There was a significant effect of Condition on the stress VAS over time (F(1,73) = 4.81, Change in stress over time by nature and urban conditions. | PMC10584913 | ||
Affect and mood | There was a significant effect of Condition on the PANAS NEG scale (F(1,73) = 11.28, Change in nature positive and negative affect over time by nature and urban conditions. | PMC10584913 | ||
Nature connection & nature spirituality | There was a significant effect of condition on the NCI (F(1,73) = 5.37, Change in nature connection and nature spirituality over time by Nature and Urban conditions. | PMC10584913 | ||
Affect regulation | There was no significant difference between the conditions on change in rumination as measured by the BSRI (F(1,73) = 1.96, | PMC10584913 | ||
Attention | In the nature condition, participants reported being more focussed and alert immediately after the experiment relative to the Urban condition (F(1,74) = 7.03, | PMC10584913 | ||
Post experiment questions | PMC10584913 | |||
Attention check | The majority of participants in the nature condition (33, 89.19% correct) and Urban condition (33, 84.62% correct) successfully completed the attention check at the end of the video. There was no difference between the two conditions (χ | PMC10584913 | ||
Acceptability and feasibility | Twenty-four participants in the Nature condition (64.86%) and 33 in the Urban condition (84.62%) reported that the video felt either ‘slightly realistic’ or ‘very realistic’ when watching it, which was a significant difference (χ | PMC10584913 | ||
Discussion | phobic, agoraphobic, depressive, depression-related low | BLIND | Our findings support both of the general hypotheses that brief exposure to an immersive nature video, relative to an urban comparison condition would (i) reduce stress and improve indices of mental wellbeing in adolescents and (ii) increase nature connection. Our novel hypothesis on increasing nature spirituality (iii)... | PMC10584913 |
Methods | PMC10584913 | |||
Procedure | RECRUITMENT | The study used an experimental design and recruited participants through opportunity sampling. Recruitment methods included social media (e.g. Facebook, Instagram, LinkedIn), posters placed around the University campus and through word of mouth. Digital and paper advertisements contained a QR code for participants to a... | PMC10584913 | |
Participants | The sample consisted of 76 adolescents (mean age = 20.42, SD = 1.15, range = 18–25) and included 61 females (85.53%), 11 males (14.47%). The majority, 65, was white (85.53%) with 11 (14.47%) participants reporting other ethnicities (3 ‘Asian’, 1 ‘Black’, 3 ‘Mixed’ and 4 ‘Other’). | PMC10584913 | ||
Conditions | PMC10584913 | |||
The virtual nature condition | visual and auditory | This condition contained a short virtual nature video (6 min) combining immersive visual and auditory aspects of both green and blue space. The recording is a point-of-view walk that begins along a woodland pathway surrounded by tall trees, followed by a section of riverside walking in the woodland, ending with a furth... | PMC10584913 | |
Urban comparison condition | This comparison condition included a recording of equivalent duration to the virtual nature condition (6:00 min) that attempted to emulate a real-world urban environment. The video is taken inside a London underground train during a busy rush hour period. The video features a virtual passenger waiting at a busy and con... | PMC10584913 | ||
Measures | PMC10584913 | |||
Short Warwickshire Edinburgh Mental Wellbeing Scale (SWEMWBS) | The SWEMWBS is a seven-item unidimensional measure of wellbeing | PMC10584913 | ||
International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) | The I-PANAS-SF is a 10-item scale measuring state positive affect (PA) and negative affect (NA) using a five-point Likert scale (1 = “not at all/ very slightly to 5 = “extremely”) | PMC10584913 | ||
Brief State Rumination Index (BSRI) | The BSRI is an eight-item scale measuring state rumination using a visual analogue scale (VAS; 0 = “completely disagree” to 100 = “completely agree”) | PMC10584913 | ||
Stress | State stress levels were measured using a VAS (0 = “completely disagree” to 100 = “completely agree”), asking participants to rate how strongly they agree with the statement “I am stressed right now”. VAS stress scales have been shown to be equal to questionnaire methods of assessing stress | PMC10584913 | ||
Perceived Stress Scale (PSS-4) | The PSS-4 | PMC10584913 | ||
Nature connection | The Nature Connection Index | PMC10584913 | ||
Nature spirituality | For the present study, a small set of items was needed to test our exploratory hypothesis on nature spirituality in adolescents whilst not overburdening participants. To ensure that items were likely to be tapping into state spirituality and therefore sensitive to change after a short duration, we used the stem of “Rig... | PMC10584913 | ||
Bespoke items | Three additional items were included following the experiment. These were “Right now, I feel relaxed/composed”. “Right now, I feel that my mood is positive”. “Right now, I can focus clearly and I feel alert”. Each item used a VAS (0–100). | PMC10584913 | ||
Feasibility and acceptability | anxiety, depressive symptoms | We asked three questions at the end of the experiment to assess feasibility and acceptability of the intervention, including, “Overall, how realistic did watching the video feel?”, “How did you find the overall length of the video? And “Would you recommend this to a friend or family member who is experiencing anxiety o... | PMC10584913 | |
Sample size calculation | We based our sample size calculation on detecting a difference in short-term psychological change following a nature-based intervention | PMC10584913 | ||
Acknowledgements | RECRUITMENT | Thanks to Emily Kekwick for assisting with the recruitment and delivery of the study. | PMC10584913 | |
Author contributions | M.O and H.B. conceived and deigned the online experiment and M.O. analysed the results. Both authors wrote and reviewed the manuscript. | PMC10584913 | ||
Competing interests | FOUNDERS | The authors declare no competing interests. Both M.O and H.B. are founders of the ROWAN group which is a non-political, non-advocacy collaboration between clinicians, academics, students and members of the public set up to investigate the connection between nature and wellbeing. | PMC10584913 | |
References | PMC10584913 | |||
Purpose | To assess study design and a range of anatomical and functional changes after internal limiting membrane (ILM) peeling using forceps developed for atraumatic ILM pick-up compared to standard forceps. | PMC10198899 | ||
Methods | FTMH, idiopathic full-thickness macular hole | We conducted a masked proof-of concept randomised controlled trial (RCT) on 65 patients who underwent ILM peeling for idiopathic full-thickness macular hole (FTMH) using etched-tip forceps (etched-tip group, 33 eyes) compared to standard ILM forceps (smooth-tip group, 32 eyes). Patients were assessed preoperatively, 3 ... | PMC10198899 | |
Results | The primary closure rate was 95.4%. There was no statistically significant difference between the groups in terms of final visual acuity (66.9 vs 70.9 ETDRS letters, | PMC10198899 | ||
Conclusions | The study was successfully completed with masking maintained and a low risk of bias. Multiple endpoints relating to ILM peeling were assessed, and estimates were provided that can be used for future studies. Although the study was not powered to assess any specific endpoint, the anatomical and functional outcomes asses... | PMC10198899 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00417-022-05932-y. | PMC10198899 | ||
Keywords | PMC10198899 | |||
Introduction | trauma | Internal limiting membrane (ILM) peeling has become an integral part of the surgical repair of primary idiopathic full-thickness macular holes (iFTMH) and is a common step in a variety of different vitreoretinal procedures, offering several advantages [Etched-tip forceps have been developed to facilitate picking up the... | PMC10198899 | |
Methods | This masked randomised controlled feasibility trial was registered on the ISRCTN registry (reference 70,557,873), and the protocol is available at | PMC10198899 | ||
Sample size | As a proof-of-concept study, the sample size was set as 60, based on the methodology of Viechtbauer et al. [ | PMC10198899 | ||
Recruitment criteria | diabetic retinopathy, VFs, FTMH, amblyopia, glaucoma | DIABETIC RETINOPATHY, BACKGROUND RETINOPATHY, AMBLYOPIA, SECONDARY, HIGH MYOPIA, MACULAR DISEASE, GLAUCOMA, INTRAOCULAR INFLAMMATION, OPTIC NERVE DISEASE | We included patients over 50 years affected by iFTMH of any size and less than 12-month duration. We excluded patients in whom ILM peeling was not planned, secondary FTMH, previously vitrectomized eyes, pre-existing significant macular disease (early/intermediate AMD allowed), glaucoma, optic nerve disease, diabetic re... | PMC10198899 |
Participants, randomisation and masking | Patients were randomised into two groups based on the forceps used for the ILM peeling: etched-tip ILM forceps in group ‘etched-tip’ and in group ‘smooth-tip’. Randomisation to study intervention was carried out by research staff using online randomisation, with a block size of 2 (REDCap, | PMC10198899 | ||
Surgical procedure | cataract, tamponade | CATARACT, SEPARATION | Surgery was standardised with 23- or 25-gauge transconjunctival pars plana vitrectomy with posterior hyaloid face separation, if not pre-existing. All phakic patients underwent combined cataract surgery. After core and peripheral vitrectomy, ILM staining was performed with heavy brilliant blue G (BBG) 0.025% for 30-s c... | PMC10198899 |
Surgery evaluation | retinal trauma | SECONDARY, RETINAL HAEMORRHAGE | Immediately following surgery, surgeons were asked to guess the type of forceps allocated, disclose any unmasking, grade the ease of ILM peel initiation, the downward force required and the ability to release the ILM from the forceps, using a 5-point scale ranging from 1 (very difficult) to 5 (very easy).Surgical video... | PMC10198899 |
Ophthalmic examination | A complete ophthalmic examination, including visual acuity (VA), slit-lamp biomicroscopy and dilated fundoscopy, was carried out preoperatively (within 14 days of surgery) and at 3 weeks, 3 and 6 months postoperatively. Visual acuity using a protocol refraction and ETDRS vision testing at 4 m was measured by masked res... | PMC10198899 | ||
Visual field protocol | Central VFs (Humphrey Field Analyzer Central 10–2 Swedish Interactive Threshold Algorithm-Standard test, Carl Zeiss Meditec, San Leandro, CA) were performed preoperatively and 6 months postoperatively. The test was performed in both eyes with the fellow eye first and repeated if they failed to achieve a pre-defined rel... | PMC10198899 | ||
Imaging protocol and analysis | streaks inferior, swelling, haemorrhages | POSTERIOR, OPTIC NERVE, HAEMORRHAGES | The Heidelberg Spectralis spectral-domain OCT device (Heidelberg Engineering, Heidelberg, Germany) was used by masked technicians. Posterior Pole scan, 30° × 25°, 240 Sects. (30 μm), high speed, ART 20 and a Peri-papillary Pre-set RNFL scan ART 100 were acquired preoperatively and at each FU. In addition, a 5° × 15°, 4... | PMC10198899 |
Statistical analysis | retinal defects, VF | RETINA | Due to randomisation, demographic and baseline characteristics were similar in the two groups, and thus, no formal statistical comparisons were made.The remaining analyses compared 3-week and 6-month outcomes between the two study groups. Due to pandemic COVID restrictions, the 3-month imaging data was only available o... | PMC10198899 |
Discussion | retinal rigidity, Müller cell foot plate avulsion, paracentral scotomata, temporal VF defects, retinal injury, trauma | RETINA | This is the first proof-of-concept RCT assessing a newly developed types of ILM peeling forceps as compared with a standard one with a wide range of anatomical and functional endpoints. As a proof-of-concept study, it was successful, and the outcomes’ validity was strengthened by the trial design with robust randomisat... | PMC10198899 |
Funding
| The study was funded as an IIS (IIT#38075469) by Alcon, with payment to Newcastle University. D Steel discloses that his institution has received research grants from Alcon, DORC, Bayer, and Boehringer-Ingleheim, and he has acted as a consultant to Alcon, Novo Nordisk, BVI, Roche, Apellis and Gyroscope for projects unr... | PMC10198899 | ||
Declarations | PMC10198899 | |||
Ethical approval and informed consent | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutions where the study was carried out and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. UK multicentre ethical approval (North of Scotland Research ... | PMC10198899 | ||
Conflict of interest | The authors declare no competing interests. | PMC10198899 | ||
References | PMC10198899 | |||
Background | Diabetes | TYPE 2 DIABETES, DIABETES | Edited by: Pranav Kumar Prabhakar, Lovely Professional University, IndiaReviewed by: Gopal L. Khatik, National Institute of Pharmaceutical Education and Research, India; Ewan Pearson, University of Dundee, United KingdomThis article was submitted to Clinical Diabetes, a section of the journal Frontiers in Endocrinology... | PMC9869378 |
Aims | obesity, hypertriglyceridemia | INSULIN RESISTANCE, OBESITY, TYPE 2 DIABETES, HYPERTRIGLYCERIDEMIA | We hypothesized that people with type 2 diabetes who generally have high insulin resistance, such as people of Māori/Pacific ethnicity, and those with obesity and/or hypertriglyceridemia (OHTG), would have greater glucose-lowering by pioglitazone (an insulin sensitizer) versus vildagliptin (an insulin secretagogue). | PMC9869378 |
Methods | weight, blood pressure, diabetes | TYPE 2 DIABETES, DIABETES | A randomised, open-label, two-period crossover trial was conducted in New Zealand. Adults with type 2 diabetes, HbA1c>58mmol/mol (>7.5%), received 16 weeks of either pioglitazone (30mg) or vildagliptin (50mg) daily, then switched to the other medication over for another 16 weeks of treatment. Differences in HbA1c were ... | PMC9869378 |
Results | weight gain | 346 participants were randomised (55% Māori/Pacific) between February 2019 to March 2020. HbA1c after pioglitazone was lower than after vildagliptin (mean difference -4.9mmol/mol [0.5%]; 95% CI -6.3, -3.5; p<0.0001). Primary intention-to-treat analysis showed no significant interaction effect by Māori/Pacific vs other ... | PMC9869378 | |
Conclusions | Comparative glucose-lowering by pioglitazone and vildagliptin is not different between Māori/Pacific people compared with other New Zealand ethnic groups. Presence of OHTG predicts greater glucose lowering by pioglitazone than vildagliptin. | PMC9869378 | ||
Clinical trial registration | PMC9869378 | |||
Introduction | obesity, Obesity, T2D, hyperglycaemia, heart failure, diabetes | OBESITY, OBESITY, RENAL DISEASE, HIGH TRIGLYCERIDES, INSULIN RESISTANCE, ELEVATED TRIGLYCERIDES, HYPERGLYCAEMIA, HEART FAILURE, TYPE 2 DIABETES, DIABETES | The epidemic of type 2 diabetes (T2D) is of significant concern due to increased morbidity, mortality, and health care costs. Current treatment guidelines recommend early use of sodium glucose transport protein 2 inhibitors (SGLT2i) and glucagon like peptide 1 receptor agonists (GLP1RA) for those with high cardiovascul... | PMC9869378 |
Materials and methods | PMC9869378 | |||
Participant eligibility | infection, T2D | INFECTION, RECRUITMENT | Patients with T2D for >1 year, who had been on stable doses of metformin and/or sulfonylurea for >3 months were eligible to participate if they were aged 18–80 years inclusive, had HbA1c > 58 mmol/mol [> 7.5%] and < 111 mmol/mol [<12.3%], had never been on DPP4i or thiazolidinedione, had no insulin use, had no active i... | PMC9869378 |
Settings and location | The trial participants were recruited at nine sites across urban (Auckland and Waikato) and rural settings (Te Tai Tokerau (Northland) and Te Tairāwhiti (East Coast of the North Island) in NZ. | PMC9869378 | ||
Trial design | We conducted an investigator-initiated, multi-centre, open-label, two-treatment (pioglitazone 30mg once daily [P], vildagliptin 50mg once daily [V]), two-period (16-weeks each), randomised, crossover trial. There was no washout period between medications because medication withdrawal could have caused detrimental rebou... | PMC9869378 | ||
Outcome and baseline measures | diabetes, co-morbidities, Diabetes | DIABETES, SECONDARY, DIABETES | The primary outcome measure was HbA1c after each 16-week treatment period. The primary analysis was to test stratification in HbA1c response by Māori or Pacific ethnicity and the pre-specific secondary analysis was to test stratification in HbA1c response by OHTG status. To minimise confounding by adherence or treatmen... | PMC9869378 |
Randomisation | Eligible participants were randomised 1:1 to one of the two sequences (VP or PV) by a central trial pharmacist using a secure trial database. The randomised study medication was couriered to the participant’s nominated address by the central trial pharmacy. Randomisation lists were prepared by the trial statistician, u... | PMC9869378 | ||
Statistical analysis | REGRESSION, SECONDARY | We aimed to recruit a total of 300 participants, with a target sample size of 40% Māori and Pacific people. This sample size would provide 80% power at 5% significance level to detect a minimal effect size of 0.35 standard deviation (SD) between Māori and Pacific vs non-Māori/non-Pacific groups on the difference in HbA... | PMC9869378 |
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