***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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results OBJECTIVES The objective of the study is to evaluate the effects of levonorgestrel transferred through breast milk on thyroid stimulating hormone ( TSH ) and luteinizing hormone ( LH ) levels in full breast-fed infants . METHODS Forty healthy postpartum women and their male newborns were recruited for the study . Women were r and omly allocated to two study groups : Group 1 , IUD users and group 2 , Norplant users . Blood and milk sample s were collected on the day of IUD or Norplant insertion and 3 and 6 months later for TSH and levonorgestrel measurements . RESULTS The results disclosed a significant decrease in TSH levels , and a negative relationship between LNG levels and TSH concentration in breast feeding infants at 3 months after implant insertion . The lowest TSH levels were observed at 6 months in the women from group 2 . CONCLUSIONS The overall data indicate that the LNG levels transferred to fully breast-fed infants through breast milk from Norplant users significantly modified their TSH levels Recent empirical evidence supports the importance of adequate r and omization in controlled trials . Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment . While that provides empirical evidence of bias being interjected into trials , trial investigators rarely document the sensitive details of subverting the intended purpose of r and omization . This article relates anonymous accounts run the gamut from simple to intricate operations , from transillumination of envelopes to search ing for code in the office files of the principal investigator . They indicate that deciphering is something more frequent than a rate occurrence . These accounts prompt some method ological recommendations to help prevent deciphering . R and omized controlled trials appear to annoy human nature -- if properly conducted , indeed they should Eighty healthy single births born at a gestational age of 259 - 294 days were studied in an open , non-r and omized , group comparative fashion . The mothers were on average 6 weeks postpartum , healthy , and fully breastfeeding at the start of treatment . Forty-two mothers elected to use the etonogestrel-releasing implant , Implanon , while 38 chose use of a non-hormone medicated intrauterine device ( IUD ) . One month after implant placement , the dose of etonogestrel ingested by the infants via breast milk was 19.86 ng/kg/day , which decreased to 10.45 ng/kg/day at the end of the study period ( month 4 ) . The volume of breast milk production was not affected by the use of Implanon . There were no significant differences between groups in milk content of total fat , total protein , and lactose . The timing and quantity of supplementary feedings did not differ between the two groups . Growth of the infants was analyzed by treatment and gender . For the girls , no differences between groups were seen for body weight , body length , and head circumference . The same applied to the boys except for a somewhat larger , although not statistically significant , increase in body weight for boys whose mother used Implanon . There was a low incidence of intercurrent illnesses in the infants of both groups . None of the conditions was of a serious nature . From the present study , we conclude that Implanon did not change the volume and composition of breast milk . The low concentration of etonogestrel ingested by the infant was not associated with adverse effects OBJECTIVE : To evaluate lactogenesis after early postpartum insertion of the etonogestrel contraceptive implant . METHODS : Healthy peripartum women with healthy , term newborns who desired the etonogestrel implant for contraception were r and omly assigned to early ( 1–3 days ) or st and ard ( 4–8 weeks ) postpartum insertion . The primary outcomes , time to lactogenesis stage II and lactation failure , were documented by a vali date d measure . The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 8 additional hours . Secondary data ( device continuation and contraceptive use , breast milk analysis , supplementation rates , side effects , and bleeding patterns ) were collected at periodic intervals for 6 months . RESULTS : Sixty-nine women were enrolled . Thirty-five were r and omly assigned to early insertion and 34 to st and ard insertion . There were no statistically significant differences between the groups in age , race , parity , mode of delivery , use of anesthesia , or prior breastfeeding experience . Early insertion was demonstrated to be noninferior to st and ard insertion in time to lactogenesis stage II ( early : [ mean±st and ard deviation ] 64.3±19.6 hours ; st and ard : 65.2±18.5 hours , mean difference , −1.4 hours , 95 % confidence interval [ CI ] −10.6 to 7.7 hours ) . Early insertion was also demonstrated to be noninferior to st and ard insertion in incidence of lactation failure ( 1/34 [ 3 % ] in the early insertion group , 0/35 [ 0 % ] in the st and ard insertion group [ risk difference , 0.03 , 95 % CI −0.02 to 0.08 ] ) . Use of formula supplementation was not significantly different between the groups . Milk composition at 6 weeks was not significantly different between the groups . CONCLUSION : Breastfeeding outcomes were similar in women who underwent early compared with st and ard postpartum insertion of the etonogestrel implant . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00847587 . LEVEL OF EVIDENCE : OBJECTIVE : To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device ( IUD ) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6–8 weeks postpartum . METHODS : We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD . Patients were r and omly assigned when admitted in labor to postplacental or delayed IUD insertion . The women followed up in person at 6–8 weeks and 6 months and were contacted by telephone at 3 months . Women were ineligible for a study IUD postenrollment for intrapartum events including infection , hemorrhage , and cesarean delivery ; these women were contacted by phone at 3 and 6 months . Expelled IUDs were replaced per patient preference . RESULTS : Successful IUD placement occurred in 50 of 51 participants ( 98.0 % ) and 46 of 51 participants ( 90.2 % ) in the postplacental and delayed groups , respectively ( P=.2 ) . Expulsion within 6 months occurred in 12 of 50 ( 24.0 % ; 95 % confidence interval [ CI ] , 13.1–38.2 ) and two of 46 ( 4.4 % ; 95 % CI 0.5–14.8 ) participants , respectively ( P=.008 ) . Intrauterine device use at 6 months was 43 of 51 ( 84.3 % ; 95 % CI 71.4–93.0 ) and 39 of 51 ( 76.5 % ; 95 % CI 62.5–87.2 ) , respectively ( P=.32 ) . For ineligible patients , only 11 of 41 ( 26.8 % ) women were using IUDs at 6 months and two ( 4.9 % ) had become pregnant . CONCLUSION : Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs . Expulsions are significantly higher with postplacental compared with delayed IUD placement . Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00476021 . LEVEL OF EVIDENCE : Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity A study was conducted to determine whether the onset or maintenance of lactation might be influenced by the administration of ovulation-inhibiting drugs for contraceptive purpose s when they were taken : 1 ) before the beginning of the lactation-period ; or 2 ) during the lactation period . The  milk yield of 100 mothers who received an ovulation inhibitor ( 2.5 . mg lynestrenol ) from Day 1 postpartum was investigated . In order to exclude psychic factors 50 % of the tablets were placebos of identical appearance . The administration of the ovulation-inhibitor from Day 1 postpartum did not influence the commencement of lactation of the total milk yield in the first 10 days of the child-bed period . No clear influence on the milk yeild was observed during the subsequent observation period of 4 weeks . No differences were observed in another double group of mothers 70 women altogether who received the ovulation-inhibitor or the placebo  from Day 10 postpartum BACKGROUND Mirena is a levonorgestrel-releasing intrauterine system ( LNG-IUS ) that provides highly effective and long-acting progestogen-only contraception . OBJECTIVE The objective of this study was to analyze the possible effects of using LNG-20 microg IUS on breast-feeding performance , infant growth and infant development during the first postpartum year as compared with the Copper T380A intrauterine device ( Cu T380A IUD ) . DESIGN This study is a prospect i ve , controlled and r and omized trial . SETTING The study was conducted at the Department of Obstetrics and Gynecology , Assiut University Hospital , Egypt . METHODS Three hundred twenty lactating women asking for initiation of contraception during the early postpartum stage were assigned r and omly into two groups , the LNG-20 microg IUS group ( n=163 ) and the Cu T380A group ( n=157 ) . The insertions were done 6 - 8 weeks postpartum . Each participant was followed up at three monthly intervals after insertion and until the first birthday of her baby . During these visits , the breast-feeding pattern was assessed , certain infant physical growth parameters were measured and a set of infant development tests was performed . RESULTS No pregnancy occurred in both groups . There were no significant differences in the net continuation rates between the two groups ( 89.3 for LNG-IUS vs. 90.9 for Cu T380A ) . The LNG-20 microg IUS group had comparable rates of breast-feeding continuation , complete weaning , full breast-feeding and partial breast-feeding , with the Cu-IUD group . No statistically significant differences were found between groups with regard to all infant physical growth parameters and various infant development tests . CONCLUSION The findings of the current study confirm that the use of LNG-20 microg IUS during the first postpartum year in lactating women provides highly effective and acceptable contraception and does not negatively influence breast-feeding or the growth and development of breast-fed infants Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as 
    Output:
    
One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA