***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: BACKGROUND Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma . Treating actinic keratoses and the surrounding skin area ( i.e. , field therapy ) can eradicate clinical and sub clinical actinic keratoses . Topical field therapy currently requires weeks or months of treatment . We investigated the efficacy and safety of a new topical field therapy for actinic keratosis , ingenol mebutate gel ( 0.015 % for face and scalp and 0.05 % for trunk and extremities ) . METHODS In four multicenter , r and omized , double-blind studies , we r and omly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo ( vehicle ) , self-applied to a 25-cm(2 ) contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities . Complete clearance ( primary outcome ) was assessed at 57 days , and local reactions were quantitatively measured . RESULTS In a pooled analysis of the two trials involving the face and scalp , the rate of complete clearance was higher with ingenol mebutate than with placebo ( 42.2 % vs. 3.7 % , P<0.001 ) . Local reactions peaked at day 4 , with a mean maximum composite score of 9.1 on the local-skin-response scale ( which ranges from 0 to 4 for six types of reaction , yielding a composite score of 0 to 24 , with higher numbers indicating more severe reactions ) , rapidly decreased by day 8 , and continued to decrease , approaching baseline scores by day 29 . In a pooled analysis of the two trials involving the trunk and extremities , the rate of complete clearance was also higher with ingenol mebutate than with placebo ( 34.1 % vs. 4.7 % , P<0.001 ) . Local skin reactions peaked between days 3 and 8 and declined rapidly , approaching baseline by day 29 , with a mean maximum score of 6.8 . Adverse events were generally mild to moderate in intensity and resolved without sequelae . CONCLUSIONS Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses . ( Funded by LEO Pharma ; Clinical Trials.gov numbers , NCT00742391 , NCT00916006 , NCT00915551 , and NCT00942604 . ) BACKGROUND In r and omized trials , fecal occult-blood testing reduces mortality from colorectal cancer . However , the duration of the benefit is unknown , as are the effects specific to age and sex . METHODS In the Minnesota Colon Cancer Control Study , 46,551 participants , 50 to 80 years of age , were r and omly assigned to usual care ( control ) or to annual or biennial screening with fecal occult-blood testing . Screening was performed from 1976 through 1982 and from 1986 through 1992 . We used the National Death Index to obtain up date d information on the vital status of participants and to determine causes of death through 2008 . RESULTS Through 30 years of follow-up , 33,020 participants ( 70.9 % ) died . A total of 732 deaths were attributed to colorectal cancer : 200 of the 11,072 deaths ( 1.8 % ) in the annual-screening group , 237 of the 11,004 deaths ( 2.2 % ) in the biennial-screening group , and 295 of the 10,944 deaths ( 2.7 % ) in the control group . Screening reduced colorectal-cancer mortality ( relative risk with annual screening , 0.68 ; 95 % confidence interval [ CI ] , 0.56 to 0.82 ; relative risk with biennial screening , 0.78 ; 95 % CI , 0.65 to 0.93 ) through 30 years of follow-up . No reduction was observed in all-cause mortality ( relative risk with annual screening , 1.00 ; 95 % CI , 0.99 to 1.01 ; relative risk with biennial screening , 0.99 ; 95 % CI , 0.98 to 1.01 ) . The reduction in colorectal-cancer mortality was larger for men than for women in the biennial-screening group ( P=0.04 for interaction ) . CONCLUSIONS The effect of screening with fecal occult-blood testing on colorectal-cancer mortality persists after 30 years but does not influence all-cause mortality . The sustained reduction in colorectal-cancer mortality supports the effect of polypectomy . ( Funded by the Veterans Affairs Merit Review Award Program and others . ) BACKGROUND Women 's groups and health education by peer counsellors can improve the health of mothers and children . We assessed their effects on mortality and breastfeeding rates  in rural Malawi . METHODS We did a 2 × 2 factorial , cluster-r and omised trial in 185,888 people in Mchinji district . 48 equal-sized clusters were r and omly allocated to four groups with a computer-generated number sequence . 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems . 72 trained volunteer peer counsellors  made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care . Primary outcomes for the women 's group intervention were maternal , perinatal , neonatal , and infant mortality rates ( MMR , PMR , NMR , and IMR , respectively ) ; and for the peer counselling were IMR and exclusive breastfeeding ( EBF ) rates . Analysis was by intention to treat . The trial is registered as IS RCT N06477126 . FINDINGS We monitored outcomes of 26,262 births between 2005 and 2009 . In a factorial model adjusted only for clustering and the volunteer peer counselling intervention , in women 's group areas , for years 2 and 3 , we noted non-significant decreases in NMR ( odds ratio 0.93 , 0.64 - 1.35 ) and MMR ( 0.54 , 0.28 - 1.04 ) . After adjustment for parity , socioeconomic quintile , and baseline measures , effects were larger for NMR ( 0.85 , 0.59 - 1.22 ) and MMR ( 0.48 , 0.26 - 0.91 ) . Because of the interaction between the two interventions , a stratified analysis was done . For women 's groups , in adjusted analyses , MMR fell by 74 % ( 0.26 , 0.10 - 0.70 ) , and NMR by 41 % ( 0.59 , 0.40 - 0.86 ) in areas with no peer counsellors , but there was no effect in areas with counsellors ( 1.09 , 0.40 - 2.98 , and 1.38 , 0.75 - 2.54 ) . Factorial analysis for the peer counselling intervention for years 1 - 3 showed a fall in IMR of 18 % ( 0.82 , 0.67 - 1.00 ) and an improvement in EBF rates ( 2.42 , 1.48 - 3.96 ) . The results of the stratified , adjusted analysis showed a 36 % reduction in IMR ( 0.64 , 0.48 - 0.85 ) but no effect on EBF ( 1.18 , 0.63 - 2.25 ) in areas without women 's groups , and in areas with women 's groups there was no effect on IMR ( 1.05 , 0.82 - 1.36 ) and an increase in EBF ( 5.02 , 2.67 - 9.44 ) . The cost of women 's groups was US$ 114 per year of life lost ( YLL ) averted and that of peer counsellors was $ 33 per YLL averted , using stratified data from single intervention comparisons . INTERPRETATION Community mobilisation through women 's groups and volunteer peer counsellor health education are methods to improve maternal and child health outcomes in poor rural population s in Africa . FUNDING Saving Newborn Lives , UK Department for International Development , and Wellcome Trust BACKGROUND Venous thromboembolism is a common , potentially avoidable cause of death and morbidity in patients in hospital , including those with stroke . In surgical patients , intermittent pneumatic compression ( IPC ) reduces the risk of deep vein thrombosis ( DVT ) , but no reliable evidence exists about its effectiveness in patients who have had a stroke . We assessed the effectiveness of IPC to reduce the risk of DVT in patients who have had a stroke . METHODS The CLOTS 3 trial is a multicentre parallel group r and omised trial assessing IPC in immobile patients ( ie , who can not walk to the toilet without the help of another person ) with acute stroke . We enrolled patients from day 0 to day 3 of admission and allocated them via a central r and omisation system ( ratio 1:1 ) to receive either IPC or no IPC . A technician who was masked to treatment allocation did a compression duplex ultrasound ( CDU ) of both legs at 7 - 10 days and , wherever practical , at 25 - 30 days after enrolment . Caregivers and patients were not masked to treatment assignment . Patients were followed up for 6 months to determine survival and later symptomatic venous thromboembolism . The primary outcome was a DVT in the proximal veins detected on a screening CDU or any symptomatic DVT in the proximal veins , confirmed on imaging , within 30 days of r and omisation . Patients were analysed according to their treatment allocation . TRIAL REGISTRATION IS RCT N93529999 . FINDINGS Between Dec 8 , 2008 , and Sept 6 , 2012 , 2876 patients were enrolled in 94 centres in the UK . The included patients were broadly representative of immobile stroke patients admitted to hospital and had a median age of 76 years ( IQR 67 - 84 ) . The primary outcome occurred in 122 ( 8·5 % ) of 1438 patients allocated IPC and 174 ( 12·1 % ) of 1438 patients allocated no IPC ; an absolute reduction in risk of 3·6 % ( 95 % CI 1·4 - 5·8 ) . Excluding the 323 patients who died before any primary outcome and 41 without any screening CDU , the adjusted OR for the comparison of 122 of 1267 patients vs 174 of 1245 patients was 0·65 ( 95 % CI 0·51 - 0·84 ; p=0·001 ) . Deaths in the treatment period occurred in 156 ( 11 % ) patients allocated IPC and 189 ( 13 % ) patients allocated no IPC died within the 30 days of treatment period ( p=0·057 ) ; skin breaks on the legs were reported in 44 ( 3 % ) patients allocated IPC and in 20 ( 1 % ) patients allocated no IPC ( p=0·002 ) ; falls with injury were reported in 33 ( 2 % ) patients in the IPC group and in 24 ( 2 % ) patients in the no-IPC group ( p=0·221 ) . INTERPRETATION IPC is an effective method of reducing the risk of DVT and possibly improving survival in a wide variety of patients who are immobile after stroke . FUNDING National Institute of Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , UK ; Chief Scientist Office of Scottish Government ; Covidien ( MA , USA ) BACKGROUND We previously reported that integrating antiretroviral therapy ( ART ) with tuberculosis treatment reduces mortality . However , the timing for the initiation of ART during tuberculosis treatment remains unresolved . METHODS We conducted a three-group , open-label , r and omized , controlled trial in South Africa involving 642 ambulatory patients , all with tuberculosis ( confirmed by a positive sputum smear for acid-fast bacilli ) , human immunodeficiency virus infection , and a CD4 + T-cell count of less than 500 per cubic millimeter . Findings in the earlier-ART group ( ART initiated within 4 weeks after the start of tuberculosis treatment ,  214 patients ) and later-ART group ( ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment ,  215 patients ) are presented here . RESULTS At baseline , the median CD4 + T-cell count was 150 per cubic millimeter , and the median viral load was 161,000 copies per milliliter , with no significant differences between the two groups . The incidence rate of the acquired immunodeficiency syndrome ( AIDS ) or death was 6.9 cases per 100 person-years in the earlier-ART group ( 18 cases ) as compared with 7.8 per 100 person-years in the later-ART group ( 19 cases ) ( incidence-rate ratio , 0.89 ; 95 % confidence interval [ CI ] , 0.44 to 1.79 ; P=0.73 ) . However , among patients with CD4 + T-cell counts of less than 50 per cubic millimeter , the incidence rates of AIDS or death were 8.5 and 26. 
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Conclusions Social characteristics like sex/gender remain hidden from analyses and interpretation in RCTs , with loss of information and embedding of error all along the path from design to interpretation , and therefore , to uptake in clinical practice .