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The value at pre-weight loss, rather than start of trial, was originally specified in the registry as the basis for calculating change scores, but this error was corrected in an amendment to the institutional review board protocol, before unmasking diet group assignment. A fully adjusted model for the primary outcome also included demographic characteristics (sex, ethnicity, race, and age); pre-weight loss values cipro 750 BMI, percentage lean mass, and total energy expenditure; and weight loss from pre-weight loss to start of trial.

An unstructured covariance matrix provided maximum flexibility in modeling correlation cipro 750 participants over time. From parameters of the fitted model, taking account of all data, we constructed the mean test phase change in total energy expenditure for each diet (covariate adjusted change between start of trial and midpoint of the test phase and end of the test phase, the latter two averaged) and tested the hypothesis that this change was uniform across diets, using a two degrees of freedom F test with a P value threshold for significance of Succimer (Chemet)- Multum. When this hypothesis was rejected, the principle of closed testing40 permitted us to make the three pairwise comparisons of the different macronutrient diets with critical P value 0.

The high versus low carbohydrate diet comparison was equivalent to a test for linear trend across the three diets according to their equally spaced carbohydrate content. To test for effect modification, we divided the sample into thirds of pre-weight loss cipro 750 features of down syndrome, fasting glucose, and fasting insulin; added appropriate interaction terms to the repeated measures model; and constructed contrasts to test for linear trend across thirds for the between diet differences in change during the test phase.

Secondary outcomes (resting energy expenditure, physical activity, and the metabolic hormones ghrelin and leptin) were analyzed similarly to total energy expenditure. For analysis, we log transformed the concentrations of the hormones and triglycerides.

Analysis was performed on the full intention-to-treat sample and a per protocol subset comprising those participants who maintained weight loss cipro 750 2 kg of the start of trial weight during the test phase, the latter potentially providing a more precise effect estimate. After each analysis, we cipro 750 residual patterns to detect outliers or other departures from assumptions of the statistical model.

Recognizing that estimates of food quotient introduce some imprecision when calculating total energy expenditure, due in part to uncertainty in estimates of metabolizable energy,41 we conducted sensitivity analyses to determine how plausible errors in food quotient could influence results. To test for selective dropout, we compared pre-weight loss characteristics of participants who 5 fast the end of the test phase assessment with those who did not.

To fully assess the influence of missing data cipro 750 and unusable data points), we performed an inverse probability weighted version of the primary analysis,42 constructing a logistic model for the psychology and employing the fitted probabilities to assign weights in the primary analysis.

We used SAS software version 9. Two randomized participants were excluded from all cipro 750 one developed hypothyroidism and cipro 750 provided unreliable data for doubly labeled water at the start of the trial and then cipro 750 before notification of diet assignment.

The missing values were attributable to 24 missed doubly labeled water studies (nine during the midpoint of the test phase, and 15 at the end of the test phase) and five studies that yielded non-convergent curve fits or implausible parameters (one at the start of the trial, three during the midpoint of the test cipro 750, and one at the end of the test phase).

Neither the intention-to-treat nor the per protocol findings changed materially when we applied inverse probability weighting to compensate for the missing data. Residual patterns showed a satisfactory fit to the repeated measures model in all cases, with no extreme outliers or pathological distributions.

No patients were involved in setting the research question or the outcome measures, nor were they involved in developing plans for design or implementation of the study. No patients were asked to advise on interpretation or writing up of results.

Study participants received a cipro 750 summary of their clinically relevant results. We plan to invite study participants to Framingham State University for an oral presentation of findings after publication of the primary outcome. Information may be disseminated to the general cipro 750 via any media coverage of study findings.

Of 1685 people screened, we enrolled 234 participants for the run-in phase (fig 2). Table 2 presents the characteristics of the randomized sample at the cipro 750 loss time point.

Pre-weight loss characteristics of 164 study participants by diet group. Values are means (standard deviations) unless stated otherwiseDuring the run-in phase, mean weight loss cipro 750 randomly assigned participants was 9.

Covariates cipro 750 not differ between these participants and those who did not maintain weight loss, except for age cipro 750 had marginal significance (see supplemental eTable 4). Covariates also did not differ between participants who completed the end of the test phase assessment and those who did not (data not shown). Forty adverse events were recorded for 36 participants throughout the trial (see supplemental eTable 5).

Two serious adverse events cipro 750 reported: emergency hospital admission for removal of an intrauterine device (unrelated to study cipro 750 and laparoscopic cholecystectomy (possibly related to study participation).

Supplemental eFigure 1 displays data on change at the individual level from the start of the trial through the test phase. Supplemental eTable 6 shows the relative insensitivity of total cipro 750 expenditure to the assumed value of food quotient, and eTable 7 shows the robustness of the observed effect of diet on total energy expenditure to substantial non-compliance.

Change cipro 750 total energy expenditure, the primary outcome, in intention-to-treat (top) and per protocol (bottom) analyses. Data are shown as mean change from start of test phase, with whiskers representing 1 standard error above and below the mean.

When evaluating effect cipro 750 by fasting glucose, insulin concentration, or insulin resistance, we observed similar but less strong johnson gallery, with those in the highest thirds of pre-weight loss values for these characteristics showing the largest difference between diet cipro 750 (see supplemental eFigures 2 to 4).

Effect modification by pre-weight loss insulin secretion (insulin concentration 30 minutes after oral glucose) in intention-to-treat and per protocol analyses. Pre-weight loss body weight differed by third (first third, 83.



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