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1 or if ten or fewer patients were enrolled or randomised.
2                                Patients were randomised 1:1 by computerised minimisation algorithm to
3                                Patients were randomised 1:1 to undergo PCI or a placebo procedure by
4                                Patients were randomised (1:1) using an interactive web response syste
5 e to the nearest NPHC and tribal status, and randomised (1:1) within strata.
6 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C
7 en September 9, 2013, and August 29, 2014, a randomised 2 x 2 x 3 factorial trial recruited 6- to 23-
8                            Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to
9  open-label 18 mug tiotropium, patients were randomised (2:2:1) using a interactive response technolo
10                            Participants were randomised (3:1) with a block size of four, to receive m
11 were screened, of whom 573 were enrolled and randomised (379 to regorafenib and 194 to placebo; popul
12                                Patients were randomised after baseline measure completion, a regular
13 nd Oct 8, 2012, 4884 women were enrolled and randomised after exclusion of patients at a non-adherent
14 o-treat population that analysed patients by randomised allocation but excluded patients found inelig
15 iduals from day 10 after vaccination in both randomised and non-randomised clusters.
16                                  We included randomised and quasi-randomised trials, controlled befor
17                   These individuals were not randomised and received neither omalizumab nor oral immu
18 l or ticagrelor during trial conduct was not randomised and was based on investigator preference.
19 allel three-arm cluster randomised trial was randomised by household, with 12-mo follow-up, in seven
20                                Patients were randomised centrally and stratified by hospital accordin
21        Patients were stratified according to randomising centre and serum alpha-fetoprotein concentra
22 re, prospective, open-label, non-inferiority randomised clinical trial (Sita-Hospital) in five hospit
23 phase 3, two-group, open-label, multicentre, randomised clinical trial at 92 hospitals in England, Sc
24 ETHODS AND In a cohort study nested within a randomised clinical trial that compared different treatm
25  designed to improve outcomes were tested in randomised clinical trials.
26 assigned to immediate vaccination and in non-randomised clusters received the vaccine immediately; va
27 after vaccination in both randomised and non-randomised clusters.
28 ws and meta-analysis, we identified studies (randomised, cohort, or cross-sectional) by searching MED
29 examined by controlling species richness and randomising community composition.
30                                          The randomised controlled ASTIC trial showed no benefit of m
31 this multicentre, pragmatic, observer-blind, randomised controlled superiority trial (IMPACT) at 15 N
32 sychosis derived from a previously published randomised controlled trial (IMPACT).
33 ducted this multicentre, open-label, phase 3 randomised controlled trial (IMvigor211) at 217 academic
34                    We did this single-blind, randomised controlled trial (OASIS) at 26 UK universitie
35        METHODS AND A single-blind, pragmatic randomised controlled trial (RCT) was conducted at eight
36                  Inclusion criteria were: 1) randomised controlled trial (RCT), quasi-RCT, before-aft
37           We did this single-blind, phase 2, randomised controlled trial (SUPEREDEN3) at four special
38                             We did a cluster randomised controlled trial among Royal Marines and Army
39  study is, to our knowledge, the first large randomised controlled trial assessing individual psychol
40 TKIs, and is being investigated in a phase 3 randomised controlled trial comparing lorlatinib to criz
41                             A parallel-group randomised controlled trial design was used.
42 served in the intervention arm of the RHIVA2 randomised controlled trial done in Hackney, London (UK)
43                                  We did this randomised controlled trial in 18 SSSs in England.
44            We did a community-based, cluster-randomised controlled trial in a rural area of North Cen
45                        The START trial was a randomised controlled trial in ART-naive HIV-positive pa
46 , phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or
47            We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-ca
48 We did a pragmatic, multicentre, open-label, randomised controlled trial in seven HIV clinics at acad
49                             We did a cluster-randomised controlled trial in two adjoining districts o
50                             We did a two-arm randomised controlled trial in women aged 70-85 years to
51                             This multicentre randomised controlled trial included patients with advan
52                                            A randomised controlled trial is needed.
53 ATION: To our knowledge, this is the largest randomised controlled trial of a psychological intervent
54 To determine the feasibility of conducting a randomised controlled trial of a specialist physiotherap
55 did a pragmatic, multicentre, parallel-group randomised controlled trial of adults with bullous pemph
56 Community Health (SEARCH) study is a cluster-randomised controlled trial of an HIV test-and-treat str
57 nt (INFORM) trial, a pragmatic, multicentre, randomised controlled trial of patients (>/=18 years) ad
58      METHODS AND We undertook a double-blind randomised controlled trial of small-quantity lipid-base
59 4907-29) and with the International Standard Randomised Controlled Trial registry (ISRCTN07742377), a
60        We did a community-level open cluster randomised controlled trial to compare the effects of a
61 ETATION: To our knowledge, this is the first randomised controlled trial to document efficacy of a re
62    METHODS AND FINDING: Multicentre, cluster-randomised controlled trial with raters masked to an onl
63                         In this multicentre, randomised controlled trial, 75 adults with type 1 diabe
64 , superiority, open-label, blinded-endpoint, randomised controlled trial, patients aged 70 years or y
65                              In this cluster-randomised controlled trial, villages were randomly and
66  this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged >/
67 s single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 1
68                             In this unmasked randomised controlled trial, we randomly assigned (1:1)
69                              In this cluster randomised controlled trial, we recruited non-pregnant a
70                                      In this randomised controlled trial, we recruited participants a
71                                      In this randomised controlled trial, we recruited patients from
72 y of life using data from an expertise-based randomised controlled trial.
73  mental disorders has not been assessed in a randomised controlled trial.
74           We did a prospective, single-site, randomised controlled trial.
75 ty of high-quality data due to a shortage of randomised controlled trials (partly because of ethical
76                              The findings of randomised controlled trials (RCT), observational studie
77           Studies were eligible if they were randomised controlled trials (RCTs) or prospective cohor
78              We performed a meta-analysis of randomised controlled trials (RCTs) to assess whether in
79 acaftor combination therapy was shown in two randomised controlled trials (RCTs)-TRAFFIC and TRANSPOR
80 analysis of observational cohort studies and randomised controlled trials (RCTs).
81 and ISI Web of Science on July 11, 2016, for randomised controlled trials and observational studies t
82 rictions from inception to Aug 15, 2017, for randomised controlled trials comparing the use of atraum
83  of individual patient included data from 17 randomised controlled trials done in 14 low-income and m
84                             We identified 13 randomised controlled trials done in 739 adults with typ
85 nt of patients receiving AIT and efficacy in randomised controlled trials for drug development could
86  two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PR
87 h liver cirrhosis, but no adequately powered randomised controlled trials have been done.
88                    We identified 19 relevant randomised controlled trials of 12 antipsychotic drugs t
89 , PubMed, Biosis, and ClinicalTrials.gov for randomised controlled trials of antipsychotics for the a
90                                     However, randomised controlled trials of diet-related factors hav
91                    The INTERACT studies were randomised controlled trials of early intensive blood pr
92                                     Emerging randomised controlled trials of physical activity and di
93                            We identified all randomised controlled trials of systemic therapies in no
94 hasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness
95   A previous aggregate data meta-analysis of randomised controlled trials showed that vitamin D suppl
96                             We included only randomised controlled trials that compared fibrinolytic
97                                          109 randomised controlled trials were eligible for inclusion
98                                   In blinded randomised controlled trials, statin therapy has been as
99 lse control disorders have shown efficacy in randomised controlled trials.
100  four mathematical modelling studies, and no randomised controlled trials.
101  [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of s
102       We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial a
103                                     We did a randomised controlled, open-label trial with a multi-arm
104                    We did a two-arm, cluster-randomised, controlled efficacy trial in two districts o
105                          In this open-label, randomised, controlled phase 3 trial done at two sites i
106                             We did a cluster-randomised, controlled trial in 12 hospitals in Guangxi,
107 a support the initiation of a multinational, randomised, controlled trial of intrathecal HPbetaCD.
108          We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months
109 n this phase 3, multinational, double-blind, randomised, controlled trial, adults (aged 18 years or o
110       For this double-blind, parallel-group, randomised, controlled trial, eligible patients had COPD
111                                      In this randomised, controlled, crossover trial, we recruited he
112                    LipiDiDiet was a 24-month randomised, controlled, double-blind, parallel-group, mu
113                                         This randomised, controlled, double-blind, parallel-group, su
114       METHODS AND This was a parallel-group, randomised, controlled, observer-blind trial.
115                                      In this randomised, controlled, open-label, superiority study, w
116                 EQoL-MDS was a single-blind, randomised, controlled, phase 2 superiority trial of adu
117 s enrolled in the international, open-label, randomised, controlled, phase 3 AZURE trial at eligible
118                                      In this randomised, controlled, phase 3 trial, we recruited pati
119  phase 2, non-inferiority, observer-blinded, randomised, controlled, single-centre trial in the Domin
120                        We did an open-label, randomised, controlled, two-arm effectiveness trial at 7
121                                      In this randomised, crossover study, we recruited men and women
122  dose was increased through week 4 until the randomised dose was achieved, then maintained over 8 wee
123 astatin 10 mg daily or matching placebo in a randomised double-blind placebo-controlled phase.
124 -label, double-blind phase for 8 weeks and a randomised, double-blind phase (parts 1 and 2, reported
125                            We did a phase 2, randomised, double-blind, active-controlled, non-inferio
126                                      In this randomised, double-blind, active-controlled, phase 3 equ
127                       In this international, randomised, double-blind, double-dummy, phase 3 trial, w
128                            We undertook this randomised, double-blind, efficacy, immunogenicity, and
129                                     We did a randomised, double-blind, multicentre phase 2 trial of a
130                                         This randomised, double-blind, multicentre, phase 3 trial was
131                                      In this randomised, double-blind, multicentre, placebo-controlle
132                                         This randomised, double-blind, multiperiod, phase 3 trial was
133                             In this phase 3, randomised, double-blind, non-inferiority trial, patient
134                                      In this randomised, double-blind, parallel-group, phase 3 trial
135                                      In this randomised, double-blind, phase 2 trial, we recruited pa
136                                     We did a randomised, double-blind, phase 3 trial in patients with
137                                      In this randomised, double-blind, phase 3b trial, we enrolled ad
138                                      In this randomised, double-blind, placebo-controlled phase 2 stu
139                         In this multicentre, randomised, double-blind, placebo-controlled phase 2 stu
140                       In this single-centre, randomised, double-blind, placebo-controlled phase 2 tri
141                                     We did a randomised, double-blind, placebo-controlled phase 2b tr
142                                     We did a randomised, double-blind, placebo-controlled pilot trial
143                                      In this randomised, double-blind, placebo-controlled trial at 59
144                        Part 1 consisted of a randomised, double-blind, placebo-controlled trial done
145                         In this multicentre, randomised, double-blind, placebo-controlled trial, adul
146                       In this single-centre, randomised, double-blind, placebo-controlled trial, pati
147                                      In this randomised, double-blind, placebo-controlled trial, we r
148 MP inhibitor doxycyline in a pre-registered, randomised, double-blind, placebo-controlled trial.
149                            We did a phase 2, randomised, double-blind, placebo-controlled, dose-escal
150                      The BELLE-2 trial was a randomised, double-blind, placebo-controlled, multicentr
151                          This was a phase 2, randomised, double-blind, placebo-controlled, multicentr
152                             In this phase 3, randomised, double-blind, placebo-controlled, multicentr
153                            We did a phase 3, randomised, double-blind, placebo-controlled, multicentr
154                                      In this randomised, double-blind, placebo-controlled, non-inferi
155                          In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FR
156                            This multicentre, randomised, double-blind, placebo-controlled, phase 3 st
157                                      In this randomised, double-blind, placebo-controlled, phase 3 tr
158                                         This randomised, double-blind, placebo-controlled, phase 3 tr
159                                      In this randomised, double-blind, placebo-controlled, phase 3 tr
160                  RADIANT-4 is a multicentre, randomised, double-blind, placebo-controlled, phase 3 tr
161              Patients were eligible for this randomised, double-blind, placebo-controlled, phase 3 tr
162                                This phase 2, randomised, double-blind, placebo-controlled, single-cen
163                              In this 1-year, randomised, double-blinded, placebo-controlled, phase 3
164 f our small trial in the context of previous randomised evidence suggest that the benefits of quarter
165            Trial continuation and additional randomised evidence will be necessary to establish the s
166 SHC as an alternative to routine care in non-randomised, exploratory proof-of-concept studies.
167                                            A randomised feasibility study was conducted recruiting pa
168 condary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achie
169          Analyses were done according to the randomised FREEDOM treatment assignments.
170  part 2 (weeks 12 and 16 for participants re-randomised from placebo to tildrakizumab; etanercept was
171 sical activity, or cognitive function across randomised groups.
172 ccrual before Dec 31, 2010; had to have been randomised in a way that precluded prior knowledge of tr
173        One patient in the olaparib group was randomised in error and did not receive study treatment.
174 o onset of diabetes over 160 weeks among all randomised individuals was 2.7 times longer with liraglu
175                                           We randomised mothers 1:1 to receive seasonally recommended
176               This study was part of the non-randomised, multi-cohort, open-label, phase 1b KEYNOTE-0
177                     Part A of these phase 2, randomised, multicentre, open-label, clinical trials enr
178                                     We did a randomised, non-inferiority trial.
179                         In this multicentre, randomised, open-label phase 2-3 trial, we recruited pat
180                      SABRINA is a two-stage, randomised, open-label phase 3 study at 113 centres in 3
181                          NEMO is an ongoing, randomised, open-label phase 3 study done at 118 hospita
182                          This was a phase 3, randomised, open-label study with a 2 x 2 factorial desi
183 ally enrolled, multicohort, multicentre, non-randomised, open-label study, adults (>/=18 years of age
184    This is the final analysis from GATSBY, a randomised, open-label, adaptive, phase 2/3 study, done
185        We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult
186                                      In this randomised, open-label, international, phase 3 trial, me
187                                      In this randomised, open-label, multicentre, phase 2 trial, 29 a
188                        We did a multicentre, randomised, open-label, phase 1/2 study of guadecitabine
189         LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients
190                                     We did a randomised, open-label, phase 3 trial (OAK) in 194 acade
191                          CheckMate 141 was a randomised, open-label, phase 3 trial in patients with r
192                  ACCL0431 was a multicentre, randomised, open-label, phase 3 trial that enrolled part
193                                      In this randomised, open-label, phase 3 trial, we recruited pati
194          In this multicentre, international, randomised, open-label, phase 3 trial, we recruited pati
195                              RESPONSE-2 is a randomised, open-label, phase 3b study assessing ruxolit
196 eleration (-0.7, 0, +0.7 m/s(2)) in a pseudo-randomised order across 4 blocks of 30 trials in both vi
197          We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in 240 centres
198                 DEPICT-1 was a double-blind, randomised, parallel-controlled, three-arm, phase 3, mul
199                                       In the randomised part of the trial we identified 4539 contacts
200  planning pregnancy, and was assessed in all randomised participants with baseline assessments.
201                                          All randomised patients were included in the time to clinica
202                                          All randomised patients with a baseline measurement and at l
203  on the full analysis set, consisting of all randomised patients, by intention to treat.
204 ion 1.1 in the full analysis population (all randomised patients, by intention-to-treat).
205 lysed by intention-to-treat in the first 437 randomised patients.
206                                            A randomised phase 2 trial of alternative dosing strategie
207                 The multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predomi
208                              CLEOPATRA was a randomised phase 3 study comparing the addition of eithe
209 RETATION: To our knowledge, OAK is the first randomised phase 3 study to report results of a PD-L1-ta
210 s well as propose a recommended schema for a randomised phase 3 trial that might potentially answer t
211 lesterolaemia enrolled in an open-label, non-randomised phase 3 trial.
212 ined patient populations of the three global randomised phase 3 trials of pirfenidone versus placebo-
213        We did this interim analysis of a non-randomised, phase 2 trial at 20 hospitals in the UK.
214                      In this open-label, non-randomised, phase 2 trial, patients aged 18-55 years, wh
215                              Part B of these randomised, phase 2, open-label clinical trials enrolled
216 RTC 18071 was a multinational, double-blind, randomised, phase 3 trial in patients with stage III cut
217                        We did an open-label, randomised, phase 3 trial of adult patients (aged >/=18
218             In this multicentre, open-label, randomised, phase 3 trial, we recruited patients from 87
219    FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and special
220           In this international, open-label, randomised, phase 3, multicentre trial, we enrolled adul
221                                      In this randomised, phase 3, open-label trial, patients were scr
222  a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Cent
223        This was a multicentre, double-blind, randomised placebo-controlled trial for which patients w
224 ial was a phase 2 double-blind, multicentre, randomised placebo-controlled trial in previously untrea
225                         In this double-blind randomised placebo-controlled trial, we enrolled undiagn
226 design was quantified by comparing simulated randomised placebo-controlled trials within the out-of-s
227                   The phase 2, double-blind, randomised, placebo-controlled MERIT-1 trial assessed ma
228 We did a double-blind, allocation concealed, randomised, placebo-controlled phase 2 trial in two inte
229                In this phase 3, multicentre, randomised, placebo-controlled study, we randomly assign
230  pilot safety cohort, we did a double-blind, randomised, placebo-controlled trial based in Doneguebou
231                       For this double-blind, randomised, placebo-controlled trial, we enrolled self-r
232                  We report two double-blind, randomised, placebo-controlled trials in adults with chr
233 d this single-centre, 150-day, double-blind, randomised, placebo-controlled, crossover trial (ReBUILD
234                                     We did a randomised, placebo-controlled, double-blind, crossover
235                                      In this randomised, placebo-controlled, double-blind, phase 2 tr
236           In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2
237                        We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) i
238  we searched bibliographic databases for non-randomised quasi-experimental or observational studies r
239                                      In this randomised, regimen-controlled, double-blind, phase 2 tr
240                                     Previous randomised renal denervation studies did not show consis
241                We did an open-label, cluster-randomised ring vaccination trial (Ebola ca Suffit!) in
242                                      In this randomised, sham-controlled trial, we enrolled adolescen
243  a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial.
244  standard high-dose chemotherapy and ongoing randomised studies will continue to aim to optimise trea
245 tive studies, 20 [37%] were quantitative non-randomised studies, four [7%] were mixed-methods studies
246 luded from analysis: three were not properly randomised, three withdrew from the study, and one was l
247  adverse events (32 in the placebo group, 32 randomised to 200 mg risankizumab, 31 randomised to 600
248 teral subcallosal cingulate white matter and randomised to 6 months of active or sham DBS, followed b
249 up, 32 randomised to 200 mg risankizumab, 31 randomised to 600 mg risankizumab); 18 had severe advers
250                            Participants were randomised to active (n=12) versus sham (n=13) DBS for 1
251                                        Those randomised to additional MT underwent thrombectomy using
252 The novel score was assessed within patients randomised to different DAPT durations (n=10 081) to ide
253  Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC)
254 fficacy outcome), in patients with acute ICH randomised to either intensive BP-lowering or standard B
255 month mortality was similar between patients randomised to intensive BP-lowering treatment and standa
256 n 6 years old, with median CD4% of 12%, were randomised to monitoring with or without 12-weekly CD4 c
257 ients with stable or responding tumours were randomised to oral AZD8931 (40 mg twice a day) or placeb
258 ed (n=48) and healthy volunteers (n=48) were randomised to receive 14 days treatment with 20 mg vorti
259 similar30%-40% of normal G6PD activity) were randomised to receive 3 d of chloroquine or dihydroartem
260 and no previous regular corticosteroids were randomised to receive once daily, inhaled budesonide 400
261                            Participants were randomised to the intervention or a treatment as usual c
262 o viral rebound and excluding those who were randomised to the placebo group) after randomisation.
263 ts were screened and 461 (86%) patients were randomised to treatment (230 for cariprazine and 231 for
264 se events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group
265 ks was the primary outcome, evaluated in all randomised treated individuals with at least one post-ba
266 ents who received at least one dose of their randomised treatment.
267 tients who received at least one dose of the randomised treatment; the safety analysis was done accor
268              We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices i
269           In this double-blind, multicentre, randomised trial (GEMINI-ACS-1) done at 371 clinical cen
270                          In this multicentre randomised trial (UK Flexible Sigmoidoscopy Screening Tr
271  stents has not been investigated in a large randomised trial in an all-comer population.
272   We did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 y
273                              In this cluster randomised trial in northwest Tanzania, eligible village
274           In this multicentre, double-blind, randomised trial in seven Danish university clinics, we
275                 We did an open-label cluster-randomised trial in villages in the Matlab region of Ban
276                                    A phase 3 randomised trial is now underway to further assess this
277        We did a phase 4, open-label, cluster randomised trial of 22 communities in rural KwaZulu-Nata
278 ernational, multicentre, open-label, phase 3 randomised trial of 5102 women with HER2-positive early
279 patients with lymphoma who were treated in a randomised trial of front-line chemotherapy with cycloph
280 eviously reported ACT II trial was a phase 3 randomised trial of patients of any age with newly diagn
281             ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for a
282 matory Thrombosis Outcomes Study (CANTOS), a randomised trial of the role of interleukin-1beta inhibi
283 DCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 year
284     METHODS AND A parallel three-arm cluster randomised trial was randomised by household, with 12-mo
285              In this multicentre, open-label randomised trial, 102 hospitals (Australia [three], Germ
286                              In this cluster-randomised trial, 68 rural communities (the clusters) in
287 ber, 2015, 55 patients were screened for our randomised trial, of whom 21 underwent randomisation.
288           In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 1
289 cy of treatments have not been compared in a randomised trial.
290 ive using data collected alongside a cluster-randomised trial.
291 dividual patient-level data meta-analysis of randomised trials done with more than 1000 patients that
292                          We identified seven randomised trials in which 5583 patients were randomly a
293 ison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-elu
294 n increased risk of falls and fractures, but randomised trials of vitamin D supplementation have had
295                                    Data from randomised trials suggest that maternal multiple micronu
296             We included randomised and quasi-randomised trials, controlled before-after studies, inte
297  cohort design had higher participation than randomised trials.
298  and efficacy has not been shown in previous randomised trials.
299 t the control group and participants not yet randomised were unaware of their allocation status.
300 uble-blind, multicentre, placebo-controlled, randomised withdrawal phase 2a trial in 25 secondary car

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