br Data analysis The data

Data analysis The data were statistically analyzed for significance by using one way analysis of variance and Fisher׳s least square difference test with significance level set at P<0.05.
Acknowledgments This work was supported by Kuwait University grant number RM01/12, YM10/13 and SRUL01/13 and College of Graduate Studies. The authors gratefully acknowledge the technical assistance of Mrs. S. Varghese, Dr. J. George, Dr. S. Mohan, Ms. L. Jacob and Dr. S. Jacob.
Data Reported data represents the observed association between insulin secretagogues׳ utilization and the adipokine profiles at the time of breast cancer diagnosis in women with neuropeptide receptors (Table 1). Data in Table 2 includes the observed correlations between adipokines stratified by type 2 diabetes mellitus pharmacotherapy and controls.
Experimental design, materials and methods
Funding sources This research was funded by the following Grant awards: Wadsworth Foundation Peter Rowley Breast Cancer Grant awarded to A.C.C. (UB Grant Number 55705, Contract CO26588), the New York State Council of Health-system Pharmacists Research and Education Foundation (NYSCHP-REF) Oncology Leadership Grant awarded to A.C.C. (UB Grant Number 50151), and the NYSCHP-REF Clinical Pharmacy Award TO A.C.C. (UB Grant Number 53967).
Acknowledgements
Data Table 1 describes the levels of 15 biomarkers of exposure to selected harmful and potentially harmful smoke constituents, along with the levels of biomarkers of exposure to nicotine, measured at baseline and after 5 days of the clinical study investigational period. Carboxyhemoglobin was measured in in blood (expressed as % of saturation of hemoglobin), nicotine and cotinine were measured in plasma (expressed in ng/mL), while the other biomarkers of exposure were measured in 24-hour urine (expressed as concentration adjusted to creatinine). Table 2 shows % of change from baseline within groups for each biomarker of exposure. Inferential analysis testing (ratio THS/CC expressed as %) using an ANCOVA model with adjustment to baseline values, sex, conventional cigarette consumption reported at screening, and study arms, is presented in Table 3.
Experimental design, materials and methods This study was designed as a controlled, randomized, three-arm parallel, single-center study in confinement [1]. After the screening visit, the study included 1day for admission, 2 days of baseline where smokers were smoking their own brand of CC, followed by a 5day randomized investigational period distributed as follows: 41 subjects were randomized to continue CC smoking, 39 subjects were randomized to smoking abstinence, and 80 subjects were randomized to switch from CC to THS 2.2. At baseline and 5 days of the investigational period, blood and 24-hour urine were collected to measure 15 biomarkers of exposure to selected HPHCs. In addition, biomarkers of exposure to nicotine were assessed. Bioanalytical work was performed by Celerion Laboratories at Celerion USA, Lincoln, NE, United States. The assays used for bioanalytical analysis and described below were implemented and validated in accordance with Celerion standard operating procedures which were written to meet the FDA Guidance to Industry [2].
Nicotine equivalents in urine Bioanalytical assays were developed to quantitate nicotine, cotinine, trans-3′-hydroxycotinine, nicotine-N-glucuronide, cotinine-N-glucuronide, and trans-3′-hydroxycotinine-O-glucuronide in human urine. To reduce the number of reassays and sample dilutions required to achieve a measurable result, two linear ranges were validated to quantitate samples from subjects that receive different treatments. For subjects that were randomized to smoking cessation a nine point standard calibrator line was established across the nicotine (10.0–1000ng/mL), cotinine (10.0–1000ng/mL), trans-3′-hydroxycotinine (10.0–1000ng/mL), nicotine-N-glucuronide (10.0–1000ng/mL), cotinine-N-glucuronide (20.0–2000ng/mL), and trans-3′-hydroxycotinine-O-glucuronide (50.0–5000ng/mL) analytical ranges. For subjects randomized to conventional cigarettes or the test product the linear ranges of nicotine (50.0–5000ng/mL), cotinine (50.0–5000ng/mL), trans-3′-hydroxycotinine (50.0–5000ng/mL), nicotine-N-glucuronide (50.0–5000ng/mL), cotinine-N-glucuronide (200–20,000ng/mL), and trans-3′-hydroxycotinine-O-glucuronide (200–20,000ng/mL) were validated. Calibration standards, quality control samples and clinical samples were supplemented with stable label internal standards (d4-nicotine, d3-cotinine, d3-trans-3′-hydroxycotinine, d3-nicotine-N-glucuronide, d3-cotinine-N-glucuronide, d3-trans-3′-hydroxycotinine-O-glucuronide). The target analytes were retained through combined liquid-liquid and solid-phase extraction processes. The eluents were dried under a stream of nitrogen gas. The extracts were reconstituted with deionized water and were injected onto an LC-MS/MS system for detection. Positive ions were monitored in multiple reaction monitoring mode.