***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The goal of the current clinical study , conducted in the United States ( US ) , was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with a primary diagnosis of generalized anxiety disorder ( GAD ; HAM-A total score ≥20 and MADRS score ≤16 ) . Subjects were r and omized ( 1:1 ) to receive vortioxetine 5 mg ( n=152 ) or placebo ( n=152 ) for 8 weeks . Efficacy was assessed using change from baseline in HAM-A total scores after 8 weeks of treatment compared with placebo , using mixed-model repeated measures ( MMRM ) analyses . Adverse events ( AEs ) were assessed throughout the study . A total of 304 subjects were r and omized ( mean age , 41.2 years ) . After 8 weeks of treatment , there was no statistically significant difference in the reduction in HAM-A total score from baseline between the Vortioxetine ( n=145 ) and placebo ( n=145 ) groups . There were no statistically significant differences in any key secondary efficacy outcome  between vortioxetine and placebo . Factors potentially contributing to the differences between the results of this study and those of one of identical design conducted outside the US are discussed . The most common treatment-emergent AEs were nausea , headache , dizziness , and dry mouth . Nausea was more frequently reported in the vortioxetine group ( 25 % vs 4.6 % for the placebo group ) . Most AEs were mild to moderate in severity . In conclusion , in this trial , vortioxetine did not improve symptoms of GAD ( compared with placebo ) over 8 weeks of treatment . Vortioxetine was well tolerated in this study Background Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Although constipation is a well-known side effect of calcium channel blockers such as verapamil , this side effect has not been evaluated in a quantitative manner . In a double-blind , r and omized , crossover trial , the effect of verapamil ( 240 mg/day ) was compared to placebo in 15 normal male volunteers . Subjects recorded their bowel movements and any side effects .  Scintigraphy was used to quantitate gastric emptying , small intestinal transit , and colonic transit . In the study period of four days , verapamil did not change the frequency , consistency , or passage of bowel movements . A significantly increased number of side effects was noted during verapamil treatment — notably abdominal pain and dry mouth . The slope of gastric emptying was not significantly different for verapamil ( 0.012±0.02 ) than for placebo ( 0.013±0.001 ) . Distal ileum filling was also not different for verapamil ( 0.41±0.13%/min ) than placebo ( 0.33±0.05%/min ) . Progression of the colonic geometric center was significantly delayed at 48 hr by verapamil ( 5.2±0.4 vs 6.2±0.23;P<0.01 ) . This study suggests that the constipating effect of verapamil is due to a delay of colonic transit and not due to an effect on upper gastrointestinal transit Background In clinical practice , clinicians often need to switch antipsychotic medications in patients with schizophrenia to optimize treatment outcomes . Here , we describe the safety and tolerability of switching existing antipsychotic treatments to asenapine or olanzapine monotherapy using various switching regimens . Methods Data were pooled from 949 patients in two 26-week r and omized double-blind studies . Patients with persistent negative symptoms of schizophrenia , stable for at least 5 months prior to screening and 1 additional month before r and omization , were r and omized to and treated with either asenapine ( n = 485 ) or olanzapine ( n = 464 ) , and were tapered off existing antipsychotic(s ) at variable rates within 28 days . Results Prior to r and omization , most patients were treated with second-generation antipsychotics ( SGAs ) ( asenapine : 79.6 % ; olanzapine : 78.2 % ) and first-generation antipsychotics ( FGAs ) ( 31.1 % ; 29.7 % ) , while depot formulations were used by 12.4 % and 11.4 % , respectively . Median time to taper off previous antipsychotics was 7 days , with approximately 40 % of patients abruptly discontinuing their previous medication . Similar percentages of patients in each group reported at least one adverse event ( AE )  ( asenapine : 76.9 % ; olanzapine : 75.2 % ) . The majority of AEs occurred within the first 28 days . The most frequently reported AEs were somnolence , insomnia , and headache . The incidence of AEs in patients switching from SGAs , FGAs , or depot medications was similar between asenapine and olanzapine ( 77.5 % vs 74.6 % , 75.5 % vs 79.7 % , 85.0 % vs 86.8 % , respectively ) . AEs were more frequent in subjects previously treated with two antipsychotics ( asenapine : 79.4 % ; olanzapine : 83.9 % ) versus one antipsychotic ( asenapine : 76.3 % ; olanzapine : 72.2 % ) in the switch period . Conclusion The presented data from post hoc pooled analyses may provide practical guidance for physicians switching partially stabilized patients with schizophrenia and persistent negative symptoms to asenapine or olanzapine Although dopamine agonists ( DAs ) are sometimes perceived as poorly tolerated by the elderly , there is little clinical evidence to support these concerns . Safety and tolerability of rotigotine have been demonstrated in four 6-month r and omized placebo-controlled studies : two in early Parkinson 's disease ( PD ) and two in advanced PD . A post hoc analysis of data from these pivotal trials was carried out to compare the adverse event ( AE ) profiles of younger and older patient population s. Data from early and advanced PD trials were separately pooled and evaluated using two age cut-offs ( < 65 vs. ≥ 65 years ; < 75 vs. ≥ 75 years ) . For most AEs , no age-related differences in incidence were observed . In the early PD pool , nausea ( 38 % vs. 30 % ) and headache ( 15 % vs. 9 % ) were more frequent in younger ( < 65 years ) compared with older ( ≥ 65 years ) patients using the 65-year age cut-off . Using the 75-year cut-off , nausea ( 36 % vs. 21 % ) was more frequent in younger patients ( < 75 years ) and dizziness ( 15 % vs. 28 % ) was more frequent in older patients ( ≥ 75 years ) . In the advanced PD pool , nausea was more frequent in younger patients using the 65-year age cut-off ( 24 % vs. 19 % ) and falls were more frequent in older patients using the 75-year age cut-off ( 8 % vs. 13 % ) . In this relatively healthy population which included only few patients aged 75 years or older , rotigotine  was generally well tolerated regardless of age . Data from more representative PD population s are required to fully assess potential risks of DA therapy in elderly patients Abstract Introduction / Objective : Executive function ( EF ) impairment in attention-deficit/hyperactivity disorder ( ADHD ) may account for behavioral symptoms such as poor concentration , impaired working memory , problems in shifting among tasks , and prioritizing and planning complex sets of tasks or completing long-term projects at work or school . Poor self-regulation and control of emotional behaviors frequently are seen in patients with ADHD . This study assessed EF behaviors  in adults with ADHD at baseline and after 4 weeks of treatment with lisdexamfetamine dimesylate ( LDX ) . Methods : Executive function behavior was assessed using the Brown Attention-Deficit Disorder Scale ( BADDS ) during the 4-week open-label dose-optimization phase prior to a 2-period , r and omized , double-blind , placebo-controlled crossover study of LDX ( 30–70 mg/day ) . The ADHD Rating Scale IV ( ADHD-RS-IV ) with adult prompts assessed ADHD symptoms . Change in EF behavioral symptoms was evaluated based on week 4 BADDS total and cluster scores ; analyses of shifts from baseline among subjects with BADDS scores < 50 , 50 to 59 , 60 to 69 , and ≥ 70 ; and scores less than or greater than baseline 90 % confidence range ( eg , reliably improved or worsened , respectively ) . Treatment-emergent adverse events ( TEAEs ) were described . Results : At week 4 , BADDS total and cluster scores were reduced ( ie , improved ; all P < 0.0001 vs baseline [ n = 127 ] ) . The ADHD-RS-IV with adult prompts scores also improved ( all P < 0.0001 vs baseline ) . At week 4 , 62.7 % of subjects had a BADDS total score of < 50 , and 78.9 % were reliably improved ; 1.4 % were reliably worsened . Common TEAEs ( ≥ 5 % ) during the dose-optimization phase were decreased appetite ( 36.6 % ) , dry mouth ( 30.3 % ) , headache ( 19.7 % ) , insomnia ( 18.3 % ) , upper respiratory tract infection ( 9.9 % ) , irritability ( 8.5 % ) , nausea ( 7.7 % ) , anxiety ( 5.6 % ) , and feeling jittery ( 5.6 % ) . Conclusion : Clinical ly optimized doses of LDX ( 30–70 mg/day ) significantly improved EF behaviors in adults with ADHD . Treatment-emergent adverse events with LDX were consistent with those observed with long-term stimulant use Background The current article is a systematic review concerning the efficacy and safety of aripiprazole in the treatment of bipolar disorder . Methods A systematic Medline and repositories search concerning the usefulness of aripiprazole in bipolar disorder was performed , with the combination of the words ' aripiprazole ' and ' bipolar ' . Results The search returned 184 articles and was last up date d on 15 April 2009 . An additional search included repositories of clinical trials and previous systematic review s specifically in order to trace unpublished trials . There were seven placebo-controlled r and omised controlled trials ( RCTs ) , six with comparator studies and one with add-on studies . They assessed the usefulness of aripiprazole in acute mania , acute bipolar depression and during the maintenance phase in comparison to placebo , lithium or haloperidol . Conclusion Aripiprazole appears effective for the treatment and prophylaxis against mania . The data on bipolar depression are so far negative , however there is a need for further study at lower dosages . The most frequent adverse effects are extrapyramidal signs and symptoms , especially akathisia , without any significant weight gain , hyperprolactinaemia or 
    Output:
    
Although many medications may affect the salivary flow rate and composition , most of the studies considered only xerostomia .