Primary Outcomes

Description: Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.

Measure: Time From Randomization to Virologic Failure

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Measure: Time From Treatment Dispensation to a Grade 3/4 Safety Event

Time: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

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Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Treatment Modification

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Secondary Outcomes

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Measure: The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Time: At Weeks 48 and 96

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Measure: Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

Time: At Weeks 48 and 96

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Description: Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).

Measure: Change in CD4 Count (Cells/mm3) From Baseline

Time: At Weeks 48 and 96

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Description: Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.

Measure: Number of Participants With Virologic Failure and Emergence of Major Resistance

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Measure: Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Total Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

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Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Triglyceride Level From Baseline

Time: At Weeks 48 and 96

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Other Outcomes

Description: Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.

Measure: Amount of Study Follow-up

Time: Follow-up time was variable, median follow-up was 138 weeks

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Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Number of Participants With Virologic Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Cumulative Probability of Not Experiencing Virologic Failure

Time: At week 48 and 96

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Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Number of Participants With a Grade 3/4 Safety Event

Time: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Time: At week 48 and 96

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Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Treatment Modification

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Treatment Modification

Time: At week 48 and 96

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Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Regimen Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

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Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Regimen Failure

Time: At week 48 and 96

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Primary Outcomes

Measure: The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.

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Secondary Outcomes

Measure: Vital signs

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Measure: Physical examinations

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Measure: Clinical laboratory tests

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Primary Outcomes

Measure: Proportion of mother with plasma HIV1 below 200 copies per ml after 8 weeks of treatment

Time: W8

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Secondary Outcomes

Measure: Proportion of women maintained with monotherapy until delivery,

Time: delivery

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Measure: Proportion of women with a VL below 50 copies per ml at delivery

Time: delivery

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Measure: Proportion of women harbouring resistant HIV strains four weeks after delivery

Time: W4 post partum

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Measure: Concentrations of studied drug in plasma and in cord-blood

Time: at delivery

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Measure: HIV-1 detection and concentrations of studied drug in vaginal secretion before and after treatment

Time: W0, W8 of treatment

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Measure: concentrations of studied drugs in the new born gastric fluid, HIV diagnostic in infant (criteria for stopping the trial at second infection)

Time: birth

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Primary Outcomes

Measure: To evaluate the lipid benefits of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with two nucleosides/nucleotides

Time: 24 weeks

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Secondary Outcomes

Measure: To evaluate the efficacy of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an ARV regimen containing Kaletra® with 2 nucleosides/nucleotides.

Time: 4 weeks, 12 weeks and 24 weeks.

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Measure: To evaluate additional safety and tolerability of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with 2 nucleosides/nucleotides.

Time: Week 24

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Primary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 48

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Description: Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events

Time: Week 96

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Description: Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Time: Baseline to Week 96

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Secondary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 96

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Measure: Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

Time: Baseline to Week 96

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Description: Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.

Measure: Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time: Baseline to Week 96

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Description: Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.

Measure: Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.

Time: Baseline to Week 96

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Description: Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.

Measure: Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Time: Baseline to Week 96

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Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

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Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

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Description: The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.

Measure: Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

Time: Week 96

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Description: The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.

Measure: Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

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Description: The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.

Measure: Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

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Measure: Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time: Baseline to Week 96

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Description: Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.

Measure: Mean Change From Baseline in Hematocrit (Fraction)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Platelet Count (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Neutrophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Monocytes (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Eosinophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Basophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Uric Acid (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Calcium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sodium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Potassium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Chloride (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Albumin (Grams/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Total Protein (Grams/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lipase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lactate (Millimoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Insulin (Picomoles/Liter)

Time: Baseline to Week 96

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Description: Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.

Measure: Mean Change From Baseline in Urine Specific Gravity

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Urine pH

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Weight (kg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Temperature (°F)

Time: Baseline to Week 96

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Description: Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Chest Measurement (cm)

Time: Baseline to Week 96

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Description: Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Waist Measurement (cm)

Time: Baseline to Week 96

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Description: Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Arm Measurement (cm)

Time: Baseline to Week 96

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Description: Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Hips Measurement (cm)

Time: Baseline to Week 96

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Description: Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Thigh Measurement (cm)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

Time: Baseline to Week 96

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Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

Time: Baseline to Week 96

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