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Easton Bell
Easton Bell

Proto Trial VERIFIED

Responsibility for overseeing the operation of the Fund rests with the Executive Committee, which comprises seven members each from Article 5 countries and non-Article 5 countries. The Committee is assisted by the Multilateral Fund Secretariat, which is based in Montreal. Since its inception, the Multilateral Fund has supported over 8,600 projects including industrial conversion, technical assistance, training and capacity building worth over US$3.9 billion.

Proto Trial

Many people in modern society have insufficient exposure to ultraviolet B (UVB) sunlight, which may lead to vitamin D deficiency. We aimed to investigate the effect of a proto-type wearable light-emitting diode (LED) device emitting UVB light on serum 25-hydroxyvitamin D levels.

A prototype wearable LED UVB device was effective for improving 25-hydroxyvitamin D status. The development of a safer wearable LED device for phototherapy may provide a novel daily, at-home option for vitamin D supplementation.

In this work, we aimed to examine the effect of a proto-type wearable LED UVB light-emitting device on vitamin D nutritional status of healthy adults. We conducted a randomized, single-blind, sham-controlled clinical trial with a relatively large study sample size.

Among 160 healthy adults enrolled in the current study, one participant did not meet the inclusion criteria and three declined to participate. Six participants were excluded due to adverse skin reactions after using the test device at the screening visit. The remaining 150 participants were randomly assigned (1:1 ratio) to the experimental and control groups. During the study period, nine participants dropped out due to adverse skin reactions, and five were excluded for study protocol deviations. Finally, the data from 136 participants (64 in the experimental group and 72 in the control group) were included in the PP analysis (Fig. 2). Table 1 compares the baseline demographic factors between the experimental and control groups. There were no significant differences in the baseline demographic characteristics and season of study enrollment between the two study groups.

The present study demonstrated that two minutes of the daily use of a proto-type wearable LED UVB light-emitting device for 4 weeks was effective in inducing the skin production of vitamin D in healthy adults. A significant difference was found in the change in serum 25(OH)D levels between the two groups after 2 and 4 weeks of intervention, supporting the efficacy of a proto-type wearable LED UVB device in improving serum 25(OH)D status.

In addition, a decrease in outdoor activities due to the Coronavirus Disease 2019 pandemic may also have contributed to a further decline in serum 25(OH)D levels in both groups. In Korea, gatherings of many people were prohibited, and telecommuting was more popular than ever during the pandemic. These social distancing measures resulted in a significant increase in the time spent indoors. Notably, considering the reasons mentioned above, our data suggest that using a proto-type wearable LED UVB device could be helpful for the maintenance of adequate serum 25(OH)D status during periods of decreased serum 25(OH)D levels.

In this study, the daily dose of UVB exposure by the active device was set as 15.6 mJ/cm2 for the safety of our participants. This dose was much less than the average minimal erythema dose, a minimal dose of UVB radiation that produces erythema in Koreans [22, 23]. We also performed UVB phototherapy on a relatively small skin area compared to other existing studies. For these reasons, although some adverse skin reactions such as mild erythema were observed in the experimental group, all of these adverse reactions were mild and reversible. Most of them were self-limited and only a few required additional treatment. The further improvement of proto-type wearable UVB devices may reduce the possibility of adverse effects, facilitating the clinical application of an advanced wearable device for vitamin D supplementation in the future.

The strengths of this study include a large study population consisting of healthy adults without medical and psychiatric comorbidities. In addition, we obtained information on the amount of sunlight exposure, dietary intake of vitamin D, and blood parameters related to vitamin D metabolism, all of which can affect serum 25(OH)D levels significantly. Moreover, our study was the first randomized controlled trial providing some evidence for the clinical application of a proto-type wearable LED UVB light-emitting device for vitamin D production in the general population.

This study also had several limitations to be considered. First, we performed PP analysis instead of intention-to-treat analysis, which may have led to selection bias. However, we found a low drop-out rate after excluding dropouts due to adverse skin reactions, and our data also found good compliance in both study groups, which could mitigate the possibility of selection bias. Second, the adverse skin reaction rate was 11.8% and this rate could be a considerable obstacle for clinical application of wearable devices for UVB phototherapy. However, all the adverse reactions had subsided without dermatological treatment. We also used the test device before intervention, to exclude participants with high risk of adverse skin reactions. In addition, we are developing a safer and more efficient device compared to the proto-type device used in this study. Third, we could not collect information on the Fitzpatrick skin type of each participant. Melanin pigment, the principal determinant of the Fitzpatrick skin type, might compromise vitamin D photosynthesis [27]. However, a recent study revealed that the inhibitory effects of melanin were limited [28]. Last, the study protocol was registered in the clinical trials registry after the initiation of the study. Although the CRIS, a Korean clinical trials registry platform, allows retrospective registration, we should have registered the study protocol in advance to meet international research standards.

Class trial assets for Yasuhiro Hagakure, who is never visually seen in the Demo Version except for his corpse. These assets are the versions used in the final game to represent when Tsumugi Shirogane is cosplaying as Yasuhiro Hagakure, as evidenced by the stylized "V" and "3" visible in his eyes.

Cisco Discovery Protocol (formerly known as CDP) is a Layer 2, media-independent, and network-independent protocol that runs on Cisco devices and enables networking applications to learn about directly connected devices nearby. This protocol facilitates the management of Cisco devices by discovering these devices, determining how they are configured, and allowing systems using different network-layer protocols to learn about each other.

Cisco Discovery Protocol is a Layer 2, media-independent, and network-independent protocol that networking applications use to learn about nearby, directly connected devices. Cisco Discovery Protocol is enabled by default. Each device configured for Cisco Discovery Protocol advertises at least one address at which the device can receive messages and sends periodic advertisements (messages) to the well-known multicast address 01:00:0C:CC:CC:CC. Devices discover each other by listening at that address. They also listen to messages to learn when interfaces on other devices are up or go down.

The SNMP management application learns protocol addresses and types of neighboring devices by retrieving the Cisco Discovery Protocol tables from SNMP agents on those devices. When enabled, the network management module (NMM) SNMP agent discovers neighboring devices and builds its local cache with information about these devices. A management workstation can retrieve this cache by sending SNMP requests to access CISCO-CDP-MIB.

If the encapsulation of an interface is changed, Cisco Discovery Protocol is reenabled on that interface even if Cisco Discovery Protocol was previously disabled. For example, when interface encapsulation changes from PPP to High-Level Data Link Control (HDLC), Cisco Discovery Protocol is reenabled on that interface even though it was explicitly disabled with the no cdp run command on that interface. This behavior is by design. The encapsulation changes the Layer 2 protocol configured for that interface and resets the interface configuration to the default Cisco Discovery Protocol state of being enabled, assuming that Cisco Discovery Protocol is enabled globally on the device.

Cisco Discovery Protocol is a Layer 2, media-independent, and network-independent protocol that runs on Cisco devices and enables networking applications to learn about nearby, directly connected devices. This protocol facilitates the management of Cisco devices and allows systems using different network layer protocols to learn about one another.

"While full-scale agriculture did not develop until much later, our study shows that trial cultivation began far earlier than previously believed, and gives us reason to rethink our ancestors' capabilities," said Prof. Sternberg. "Those early ancestors were more clever and more skilled than we knew."

Although weeds are considered a threat or nuisance in farming, their presence at the site of the Ohalo II people's camp revealed the earliest signs of trial plant cultivation -- some 11 millennia earlier than conventional ideas about the onset of agriculture.

Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: 041b061a72


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