“…The primary efficacy endpoint was the change of the mean pain intensity, based on an 11-point numerical rating scale, between the baseline and the last week of treatment, with the primary efficacy analysis of intention to treat. The ratio between exposed and unexposed groups was designed to be 3:1 in order to increase the likelihood of demonstrating the AGC effect upon repeated measures. …”
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“…The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). …”
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“…METHODS: We conducted a quasi-experimental repeated measures pilot study in two primary schools in the Stirling Council area: one school with, and one without, intention to introduce the Daily Mile. Pupils at the control school followed their usual curriculum. …”
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“…Treatment effects [mean (standard error)] at 12 weeks on forced expiratory volume in 1 s and St George’s Respiratory Questionnaire score were obtained from the intention-to-treat populations of two head-to-head studies [GSK study identifiers 201316 (NCT02207829) and 201315 (NCT02236611)] which compared UMEC 62.5 mcg with TIO 18 mcg and UMEC 62.5 mcg with GLY 50 mcg, respectively. …”
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“…Statistical analysis was primarily by intention to treat. RESULTS: In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). …”
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“…The primary outcome was number of inpatient bed-days, change in Strengths and Difficulties Questionnaire (SDQ) scores, and change in Children's Global Assessment Scale (CGAS) scores at 6 months, assessed by intention to treat. Cost-effectiveness was explored with acceptability curves based on CGAS scores and quality-adjusted life-years (QALYs) calculated from the three-level EuroQol measure of health-related quality of life (EQ-5D-3L), taking a health and social care perspective. …”
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“…In the best fit model (p <0.001), approximately 40% of the variability of the mean annual cost per patient was explained by the region of residence; medication used (intention to treat); if the patient was a non-exclusive user of medicines, i.e., used SUS for other procedures other than high-cost medicines; year of treatment start; and presence of events (death; Relapse; change of treatment and/or comorbidity). …”
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“…The aim of the trial is to determine the efficacy, feasibility and acceptability of email-delivered psychological interventions with telephone support, for adults injured in a motor vehicle crash engaged in seeking compensation. The primary intention for this preliminary analysis was to investigate those who were psychologically distressed and to stop the trial midway to evaluate whether the safety endpoints were necessary. …”
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“…METHODS: From the French Hospital Database on HIV (ANRS CO4), we selected heavily treated individuals (prior exposure to at least 2 nucleoside reverse transcriptase inhibitor (NRTI), 2PI and 1 NNRTI) with viral load (VL) > 50 copies/mL who started a new antiretroviral (ARV) regimen between 2005 and 2011. Using an intention-to-continue-treatment approach, hospitalization rates were calculated for the individuals who received ETR + PI, during the months after initiating ETR + PI (ETR + PI) or for the individuals who received ETR + PI, in the months before ETR + PI initiation and for the individuals who never received ETR + PI (no ETR + PI). hospitalization from an AIDS-defining cause and hospitalization from a non-AIDS defining cause rates were also calculated. …”
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“…Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. …”
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“…Dietary compliance was monitored with the use of weighed food diaries at weeks 3 and 12. RESULTS: Intention-to-treat (ITT) and completers analyses showed that the SW group lost more weight than the SC group [ITT: −5.9% (95% CI: −4.7%, –7.2%) compared with −3.5% (−2.3%, −4.8%), P < 0.05; completers: −6.2% (−4.8%, −7.6%) compared with 3.9% (−2.5%, −5.2%), P < 0.05]. …”
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“…METHODS: A randomised controlled trial with factorial allocation and intention-to-treat analysis was performed in hemodialysis patients. …”
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“…RESULTS: The main criterion was the variation from baseline of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, pain subscale (A) score (range 0-100), at 60 days, which was reduced by 28.9 (17.4) for the intent-to-treat population (199 patients), 28.0 (17.8) for the per protocol at inclusion population (175 patients), and by 27.7 (16.8) for the per protocol completed population (143 patients). …”
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“…The primary endpoint was at least a doubling of total intratumoural doxorubicin concentration in at least half of the patients treated, on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT02181075, and is now closed to recruitment. …”
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“…However, usage and future consideration to use online patient feedback websites were found to be extremely low, with current patient usage at just 0.4% (3/844), and patient intention to use online patient feedback in the future at 17.8% (150/844). …”
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“…Data from 478 households (239 in each arm) were included in the intention-to-treat analysis, with the household as the unit of analysis. …”
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“…MATERIALS AND METHODS: A cross-sectional study was carried out on 52 calves that were up to 1 year old in 38 dairy farms (mean±standard deviation: Herd size=1.71±0.7 milking cows and milk production=6.7±3.1 L/day) in Meru, Kenya, in 2017, with the intention to describe their comfort and determine the factors associated with leg hygiene as a critical parameter for calf comfort assessment. …”
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“…PBO at 16 weeks in the modified intent-to-treat (mITT) population (≥ 1 post-baseline HbA1c while on study drug), using a mixed-effects repeated measures model. …”
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“…The coprimary outcomes were assessed both in the full intent-to-treat population and in those individuals randomized to TI who were compliant with supplemental doses ≥90% of the time (n = 15). …”
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“…The primary efficacy analysis population were all participants who received the study drug and completed 12-month follow-up (modified intention to treat). This study is registered with ClinicalTrials.gov, number NCT00790998. …”
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